- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05675410
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
Study Overview
Status
Intervention / Treatment
- Drug: Etoposide
- Biological: Nivolumab
- Other: Questionnaire Administration
- Procedure: Biospecimen Collection
- Drug: Cyclophosphamide
- Drug: Prednisone
- Drug: Vincristine Sulfate
- Drug: Dacarbazine
- Drug: Doxorubicin Hydrochloride
- Drug: Vinblastine Sulfate
- Drug: Brentuximab Vedotin
- Drug: Etoposide Phosphate
- Drug: Prednisolone
- Procedure: Computed Tomography
- Biological: Bleomycin Sulfate
- Other: Fludeoxyglucose F-18
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Radiation: Involved-site Radiation Therapy
- Drug: Procarbazine Hydrochloride
Detailed Description
PRIMARY OBJECTIVES:
I. To compare the progression-free survival (PFS) of a standard chemotherapy approach versus an immunotherapy (IO) approach (brentuximab vedotin and nivolumab) in patients with newly diagnosed early stage classic Hodgkin lymphoma (cHL) who have a rapid early response (RER) as determined by position emission tomography post cycle 2 (PET2) after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy.
II. To compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) plus involved site radiation therapy (ISRT) in patients with newly diagnosed early stage cHL who have a slow early response (SER) as determined by PET2 after 2 cycles of ABVD chemotherapy.
SECONDARY OBJECTIVES:
I. To demonstrate non-inferiority of overall survival (OS) at 12 years of IO therapy versus standard therapy in early stage cHL patients who have a RER as determined by PET2 after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy.
II. To evaluate the overall survival (OS) at 12 years of IO therapy versus standard therapy in early stage cHL patients who have a SER as determined by PET2 after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy.
III. To demonstrate non-inferiority of overall survival (OS) at 12 years of IO therapy versus standard therapy in early stage cHL patients.
IV. To evaluate in patients with newly diagnosed early stage cHL the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) in the overall cohort, in the favorable risk cohort, and in the unfavorable risk cohort.
V. To evaluate the event-free survival (EFS) at 12 years of patients undergoing standard chemotherapy versus an IO therapy approach (brentuximab vedotin and nivolumab).
VI. To compare the physician-reported treatment-related adverse event (AE) rates between a standard chemotherapy approach and an IO therapy approach (brentuximab vedotin and nivolumab) in patients with newly diagnosed early stage cHL.
VII. To compare patient-reported adverse events using pediatric and adult versions of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), stratified by age groups, therapeutic arms, and receipt of radiation therapy (RT) over time.
VIII. To evaluate changes in patient-reported fatigue, cognitive functioning, and health-related quality of life (HRQoL), e.g., emotional, physical, and role functioning, by treatment arm, using validated adult and pediatric measurement systems.
IX. To evaluate self-reported late morbidities (e.g., cardiovascular, pulmonary and endocrine) over time for children, adolescents and adults undergoing standard chemotherapy versus an IO therapy approach (brentuximab vedotin and nivolumab) with and without RT using measures from the St. Jude Lifetime Cohort Study (SJLIFE).
X. To evaluate fludeoxyglucose F-18 (FDG)-position emission tomography (PET) measurements of metabolic tumor burden (MTV and total lesion glycolysis [TLG]) at PET at baseline (PET1) as a predictive marker of PFS.
XI. To evaluate the associations between race/ethnicity and key outcomes including early response to therapy, PFS and OS.
EXPLORATORY OBJECTIVES:
I. To evaluate the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) in patients with newly diagnosed early stage cHL across different age groups (ages 5-11 years, 12-21 years, 22-39 years, 40-60 years).
II. To bank specimens for future correlative studies. III. To assess concordance and discordance of rapid central review and local institutional review of FDG PET 5-point score (5-PS; previously referred to as Deauville score) at baseline PET1, interim PET2 and end of systemic therapy PET-end of systemic therapy (EST) SER.
IV. To assess the association between PFS and the quantitative FDG-PET/computed tomography (CT) parameters (PET MTV, TLG, delta-standardized uptake value [SUV] and PET SUV-based quantitative surrogates [qPET] of visual qualitative 5-PS) on measurements by automated measurements using convolutional neural networks (CNNs) through artificial-intelligence (AI) machine learning in the entire population.
V. To assess the agreement between quantitative FDG-PET/CT parameters obtained using AI and those based on measurements by a trained imaging physician.
VI. To compare patient-reported adverse events (via pediatric [Ped]-PRO-CTCAE and PRO-CTCAE) to provider adverse event reporting.
VII. To evaluate the association between self-reported race/ethnicity and social determinants of health.
VIII. To evaluate the associations between race/ethnicity and post-progression/post-relapse overall survival.
IX. To evaluate the completion rates of PRO and health-related quality of life (HRQoL) contact forms at 1 year off treatment for the first 450 eligible patients.
X. To collect contact information from participants for future re-contact.
OUTLINE: Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive 2 cycles of ABVD regimen (doxorubicin hydrochloride intravenously [IV], bleomycin sulfate IV, vinblastine sulfate IV, and dacarbazine IV) on days 1 and 15 of each treatment cycle. Each treatment cycle lasts 28 days. Patients then undergo early response assessment and are randomized to 1 of 8 arms.
ARM A (RER, FAVORABLE): Patients receive ABVD IV for an additional 2 cycles on study. Each cycle lasts 28 days and ABVD is administered on days 1 and 15 of each cycle. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo blood sample collection on trial.
ARM B (RER, FAVORABLE): Patients receive brentuximab vedotin IV and nivolumab IV once during each treatment cycle. Each cycle lasts 21 days. Treatment continues for 4 cycles. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
ARM C (SER, FAVORABLE): Patients receive eBEACOPP regimen (doxorubicin hydrochloride IV on day 1, cyclophosphamide IV on day 1, etoposide or etoposide phosphate IV on days 1-3, prednisone or prednisolone orally [PO] daily for the first 14 days of each treatment cycle, procarbazine hydrochloride PO on days 1-7, bleomycin sulfate IV on day 8, and vincristine sulfate IV) on day 8 of each treatment cycle. Treatment continues for 2 cycles. Each cycle lasts 21 days. Subsequently, patients undergo ISRT. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
ARM D (SER, FAVORABLE): Patients receive brentuximab vedotin IV and nivolumab IV as in arm B followed by ISRT. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
ARM E (RER, UNFAVORABLE): Patients receive AVD regimen (doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV) on days 1 and 15 of each treatment cycle. Each cycle lasts 28 days. Treatment continues for 4 cycles. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
ARM F (RER, UNFAVORABLE): Patients receive treatment as in arm B. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
ARM G (SER, UNFAVORABLE): Patients receive treatment and imaging, and may undergo blood sample collection as in arm C.
ARM H (SER, UNFAVORABLE): Patients receive treatment and imaging, and may undergo blood sample collection as in arm D.
After completion of study treatment, patients are followed up every 3 months for the first year, then every 6 months for the second and third year, then annually until 12 years from date of registration.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Quebec, Canada, G1V 4G2
- Recruiting
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
-
Principal Investigator:
- Bruno Michon
-
Contact:
- Site Public Contact
- Phone Number: 418-525-4444
- Email: rechclinique@crchudequebec.ulaval.ca
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2B7
- Recruiting
- University of Alberta Hospital
-
Contact:
- Site Public Contact
- Phone Number: 780-407-8798
- Email: pedsoncologyresearch@ahs.ca
-
Principal Investigator:
- Sarah J. McKillop
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0V9
- Recruiting
- CancerCare Manitoba
-
Contact:
- Site Public Contact
- Phone Number: 866-561-1026
- Email: ctu_web@cancercare.mb.ca
-
Principal Investigator:
- Ashley Chopek
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- Recruiting
- IWK Health Centre
-
Contact:
- Site Public Contact
- Phone Number: 902-470-8520
- Email: Research@iwk.nshealth.ca
-
Principal Investigator:
- Craig Erker
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- Recruiting
- Hospital for Sick Children
-
Contact:
- Site Public Contact
- Phone Number: 416-813-7654
- Email: ask.CRS@sickkids.ca
-
Principal Investigator:
- Angela S. Punnett
-
-
Quebec
-
Montreal, Quebec, Canada, H3H 1P3
- Recruiting
- The Montreal Children's Hospital of the MUHC
-
Contact:
- Site Public Contact
- Phone Number: 514-412-4445
- Email: info@thechildren.com
-
Principal Investigator:
- Stephanie Mourad
-
Montreal, Quebec, Canada, H3T 1C5
- Recruiting
- Centre Hospitalier Universitaire Sainte-Justine
-
Principal Investigator:
- Monia Marzouki
-
Contact:
- Site Public Contact
- Phone Number: 514-345-4931
- Email: yvan.samson@umontreal.ca
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Recruiting
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
-
Contact:
- Site Public Contact
- Phone Number: 819-820-6480
- Email: crcinformation.chus@ssss.gouv.qc.ca
-
Principal Investigator:
- Josee Brossard
-
-
-
-
-
San Juan, Puerto Rico, 00926
- Recruiting
- University Pediatric Hospital
-
Contact:
- Site Public Contact
- Phone Number: 787-474-0333
-
Principal Investigator:
- Maria E. Echevarria
-
-
-
-
Alabama
-
Mobile, Alabama, United States, 36604
- Recruiting
- USA Health Strada Patient Care Center
-
Contact:
- Site Public Contact
- Phone Number: 800-388-8721
-
Principal Investigator:
- Hamayun Imran
-
-
Alaska
-
Anchorage, Alaska, United States, 99508
- Recruiting
- Providence Alaska Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 907-212-6871
- Email: AKPAMC.OncologyResearchSupport@providence.org
-
Principal Investigator:
- Nitya Alluri
-
-
Arizona
-
Goodyear, Arizona, United States, 85338
- Recruiting
- CTCA at Western Regional Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 623-207-3000
-
Principal Investigator:
- Jeffrey R. Schriber
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202-3591
- Recruiting
- Arkansas Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 501-364-7373
-
Principal Investigator:
- David L. Becton
-
-
California
-
Downey, California, United States, 90242
- Recruiting
- Kaiser Permanente Downey Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 626-564-3455
-
Principal Investigator:
- Robert M. Cooper
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Principal Investigator:
- Alex F. Herrera
-
Irvine, California, United States, 92618
- Recruiting
- City of Hope at Irvine Lennar
-
Contact:
- Site Public Contact
- Phone Number: 877-467-3411
-
Principal Investigator:
- Alex F. Herrera
-
Loma Linda, California, United States, 92354
- Recruiting
- Loma Linda University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 909-558-4050
-
Principal Investigator:
- Albert Kheradpour
-
Long Beach, California, United States, 90806
- Recruiting
- Miller Children's and Women's Hospital Long Beach
-
Contact:
- Site Public Contact
- Phone Number: 562-933-5600
-
Principal Investigator:
- Jacqueline N. Casillas
-
Los Angeles, California, United States, 90027
- Recruiting
- Children's Hospital Los Angeles
-
Contact:
- Site Public Contact
- Phone Number: 323-361-4110
-
Principal Investigator:
- Andrew Doan
-
Oakland, California, United States, 94611
- Recruiting
- Kaiser Permanente-Oakland
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Aarati V. Rao
-
Orange, California, United States, 92868
- Recruiting
- Children's Hospital of Orange County
-
Contact:
- Site Public Contact
- Phone Number: 714-509-8646
- Email: oncresearch@choc.org
-
Principal Investigator:
- Elyssa M. Rubin
-
San Diego, California, United States, 92123
- Recruiting
- Rady Children's Hospital - San Diego
-
Contact:
- Site Public Contact
- Phone Number: 858-966-5934
-
Principal Investigator:
- William D. Roberts
-
South Pasadena, California, United States, 91030
- Recruiting
- City of Hope South Pasadena
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Principal Investigator:
- Alex F. Herrera
-
Upland, California, United States, 91786
- Recruiting
- City of Hope Upland
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Principal Investigator:
- Alex F. Herrera
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Recruiting
- Connecticut Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 860-545-9981
-
Principal Investigator:
- Michael S. Isakoff
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Recruiting
- Alfred I duPont Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Ramamoorthy Nagasubramanian
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Recruiting
- Children's National Medical Center
-
Principal Investigator:
- Jeffrey S. Dome
-
Contact:
- Site Public Contact
- Phone Number: 202-476-2800
- Email: OncCRC_OnCall@childrensnational.org
-
Washington, District of Columbia, United States, 20007
- Recruiting
- MedStar Georgetown University Hospital
-
Contact:
- Site Public Contact
- Phone Number: 202-444-2223
-
Principal Investigator:
- Caileigh Pudela
-
-
Florida
-
Fort Lauderdale, Florida, United States, 33316
- Recruiting
- Broward Health Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Hector M. Rodriguez-Cortes
-
Fort Myers, Florida, United States, 33908
- Recruiting
- Golisano Children's Hospital of Southwest Florida
-
Contact:
- Site Public Contact
- Phone Number: 239-343-5333
- Email: molly.arnstrom@leehealth.org
-
Principal Investigator:
- Emad K. Salman
-
Gainesville, Florida, United States, 32610
- Recruiting
- University of Florida Health Science Center - Gainesville
-
Contact:
- Site Public Contact
- Phone Number: 352-273-8010
- Email: cancer-center@ufl.edu
-
Principal Investigator:
- William B. Slayton
-
Hollywood, Florida, United States, 33021
- Recruiting
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 954-265-1847
- Email: OHR@mhs.net
-
Principal Investigator:
- Iftikhar Hanif
-
Jacksonville, Florida, United States, 32207
- Recruiting
- Nemours Children's Clinic-Jacksonville
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Ramamoorthy Nagasubramanian
-
Miami, Florida, United States, 33155
- Recruiting
- Nicklaus Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 888-624-2778
-
Principal Investigator:
- Maggie E. Fader
-
Orlando, Florida, United States, 32806
- Recruiting
- Arnold Palmer Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 321-841-5357
- Email: Jennifer.spinelli@orlandohealth.com
-
Principal Investigator:
- Amy A. Smith
-
Orlando, Florida, United States, 32827
- Recruiting
- Nemours Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Ramamoorthy Nagasubramanian
-
Pensacola, Florida, United States, 32504
- Recruiting
- Sacred Heart Hospital
-
Contact:
- Site Public Contact
- Phone Number: 850-416-4611
- Email: eebrou@ascension.org
-
Principal Investigator:
- Jeffrey H. Schwartz
-
Saint Petersburg, Florida, United States, 33701
- Recruiting
- Johns Hopkins All Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 727-767-4784
- Email: Ashley.Repp@jhmi.edu
-
Principal Investigator:
- Jennifer B. Dean
-
Tampa, Florida, United States, 33606
- Recruiting
- Tampa General Hospital
-
Contact:
- Site Public Contact
- Phone Number: 813-844-7829
- Email: syapchanyk@tgh.org
-
Principal Investigator:
- Andrew J. Galligan
-
Tampa, Florida, United States, 33607
- Recruiting
- Saint Joseph's Hospital/Children's Hospital-Tampa
-
Contact:
- Site Public Contact
- Phone Number: 813-357-0849
- Email: jennifer.manns@baycare.org
-
Principal Investigator:
- Don E. Eslin
-
West Palm Beach, Florida, United States, 33407
- Recruiting
- Saint Mary's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 561-881-2815
-
Principal Investigator:
- Matthew D. Ramirez
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Children's Healthcare of Atlanta - Egleston
-
Contact:
- Site Public Contact
- Phone Number: 404-785-2025
- Email: Leann.Schilling@choa.org
-
Principal Investigator:
- Diana Fridlyand
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University Hospital/Winship Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 404-778-1868
-
Principal Investigator:
- Jason T. Romancik
-
Atlanta, Georgia, United States, 30303
- Recruiting
- Grady Health System
-
Contact:
- Site Public Contact
- Phone Number: 404-489-9164
-
Principal Investigator:
- Jason T. Romancik
-
Atlanta, Georgia, United States, 30308
- Recruiting
- Emory University Hospital Midtown
-
Contact:
- Site Public Contact
- Phone Number: 888-946-7447
-
Principal Investigator:
- Jason T. Romancik
-
Atlanta, Georgia, United States, 30342
- Recruiting
- Emory Saint Joseph's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 404-851-7115
-
Principal Investigator:
- Jason T. Romancik
-
Atlanta, Georgia, United States, 30308
- Recruiting
- Emory Proton Therapy Center
-
Contact:
- Site Public Contact
- Phone Number: 404-251-2854
- Email: allyson.anderson@emory.edu
-
Principal Investigator:
- Jason T. Romancik
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96826
- Recruiting
- Kapiolani Medical Center for Women and Children
-
Contact:
- Site Public Contact
- Phone Number: 808-983-6090
-
Principal Investigator:
- Wade T. Kyono
-
-
Idaho
-
Boise, Idaho, United States, 83712
- Recruiting
- Saint Luke's Cancer Institute - Boise
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Nitya Alluri
-
Fruitland, Idaho, United States, 83619
- Recruiting
- Saint Luke's Cancer Institute - Fruitland
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Nitya Alluri
-
Meridian, Idaho, United States, 83642
- Recruiting
- Saint Luke's Cancer Institute - Meridian
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Nitya Alluri
-
Nampa, Idaho, United States, 83686
- Recruiting
- Saint Luke's Cancer Institute - Nampa
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Nitya Alluri
-
Twin Falls, Idaho, United States, 83301
- Recruiting
- Saint Luke's Cancer Institute - Twin Falls
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Nitya Alluri
-
-
Illinois
-
Aurora, Illinois, United States, 60504
- Recruiting
- Rush - Copley Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 630-978-6212
- Email: Cancer.Research@rushcopley.com
-
Principal Investigator:
- Priyank P. Patel
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 773-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
Principal Investigator:
- Tara O. Henderson
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois
-
Contact:
- Site Public Contact
- Phone Number: 312-355-3046
-
Principal Investigator:
- Dipti S. Dighe
-
Danville, Illinois, United States, 61832
- Recruiting
- Carle at The Riverfront
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Priyank P. Patel
-
Effingham, Illinois, United States, 62401
- Recruiting
- Carle Physician Group-Effingham
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Priyank P. Patel
-
Mattoon, Illinois, United States, 61938
- Recruiting
- Carle Physician Group-Mattoon/Charleston
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Priyank P. Patel
-
Maywood, Illinois, United States, 60153
- Recruiting
- Loyola University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 708-226-4357
-
Principal Investigator:
- Eugene Suh
-
Oak Lawn, Illinois, United States, 60453
- Recruiting
- Advocate Children's Hospital-Oak Lawn
-
Contact:
- Site Public Contact
- Phone Number: 847-723-7570
-
Principal Investigator:
- Rebecca E. McFall
-
Park Ridge, Illinois, United States, 60068
- Recruiting
- Advocate Children's Hospital-Park Ridge
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
Principal Investigator:
- Rebecca E. McFall
-
Shiloh, Illinois, United States, 62269
- Recruiting
- Memorial Hospital East
-
Contact:
- Site Public Contact
- Phone Number: 314-747-9912
- Email: dschwab@wustl.edu
-
Principal Investigator:
- Nancy L. Bartlett
-
Springfield, Illinois, United States, 62702
- Recruiting
- Southern Illinois University School of Medicine
-
Contact:
- Site Public Contact
- Phone Number: 217-545-7929
-
Principal Investigator:
- Gregory P. Brandt
-
Urbana, Illinois, United States, 61801
- Recruiting
- Carle Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Priyank P. Patel
-
Yorkville, Illinois, United States, 60560
- Recruiting
- Rush-Copley Healthcare Center
-
Contact:
- Site Public Contact
- Phone Number: 630-978-6212
- Email: Cancer.Research@rushcopley.com
-
Principal Investigator:
- Priyank P. Patel
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Riley Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 800-248-1199
-
Principal Investigator:
- Jennifer A. Belsky
-
Indianapolis, Indiana, United States, 46260
- Recruiting
- Ascension Saint Vincent Indianapolis Hospital
-
Contact:
- Site Public Contact
- Phone Number: 317-338-2194
- Email: research@stvincent.org
-
Principal Investigator:
- Bassem I. Razzouk
-
-
Iowa
-
Des Moines, Iowa, United States, 50309
- Recruiting
- Blank Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 515-241-8912
- Email: samantha.mallory@unitypoint.org
-
Principal Investigator:
- Samantha L. Mallory
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa/Holden Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-237-1225
-
Principal Investigator:
- David S. Dickens
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Recruiting
- University of Kentucky/Markey Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 859-257-3379
-
Principal Investigator:
- James T. Badgett
-
Louisville, Kentucky, United States, 40202
- Recruiting
- Norton Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 502-629-5500
- Email: CancerResource@nortonhealthcare.org
-
Principal Investigator:
- Ashok B. Raj
-
Louisville, Kentucky, United States, 40202
- Recruiting
- The James Graham Brown Cancer Center at University of Louisville
-
Principal Investigator:
- Mohamed M. Hegazi
-
Contact:
- Site Public Contact
- Phone Number: 502-562-3429
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70118
- Recruiting
- Children's Hospital New Orleans
-
Contact:
- Site Public Contact
- Email: CHResearch@lcmchealth.org
-
Principal Investigator:
- Lolie C. Yu
-
New Orleans, Louisiana, United States, 70121
- Recruiting
- Ochsner Medical Center Jefferson
-
Contact:
- Site Public Contact
- Phone Number: 504-842-8084
- Email: Elisemarie.curry@ochsner.org
-
Principal Investigator:
- Craig Lotterman
-
-
Maine
-
Bangor, Maine, United States, 04401
- Recruiting
- Eastern Maine Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 207-973-4274
-
Principal Investigator:
- Daniel L. Callaway
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Principal Investigator:
- Stacy L. Cooper
-
Contact:
- Site Public Contact
- Phone Number: 410-955-8804
- Email: jhcccro@jhmi.edu
-
Baltimore, Maryland, United States, 21215
- Recruiting
- Sinai Hospital of Baltimore
-
Contact:
- Site Public Contact
- Phone Number: 410-601-6120
- Email: pridgely@lifebridgehealth.org
-
Principal Investigator:
- Jason M. Fixler
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
-
Principal Investigator:
- Ann S. LaCasce
-
Contact:
- Site Public Contact
- Phone Number: 877-442-3324
-
Worcester, Massachusetts, United States, 01655
- Recruiting
- UMass Memorial Medical Center - University Campus
-
Contact:
- Site Public Contact
- Phone Number: 508-856-3216
- Email: cancer.research@umassmed.edu
-
Principal Investigator:
- Stefanie R. Lowas
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- C S Mott Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-865-1125
-
Principal Investigator:
- Emily B. Walling
-
Battle Creek, Michigan, United States, 49017
- Recruiting
- Bronson Battle Creek
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Dearborn, Michigan, United States, 48124
- Recruiting
- Beaumont Hospital - Dearborn
-
Contact:
- Site Public Contact
- Phone Number: 248-551-7695
-
Principal Investigator:
- Laura K. Gowans
-
Detroit, Michigan, United States, 48201
- Recruiting
- Children's Hospital of Michigan
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
Principal Investigator:
- Meret Henry
-
East Lansing, Michigan, United States, 48824
- Recruiting
- Michigan State University Clinical Center
-
Contact:
- Site Public Contact
- Phone Number: 517-975-9547
-
Principal Investigator:
- Laura E. Agresta
-
Farmington Hills, Michigan, United States, 48336
- Recruiting
- Beaumont Hospital - Farmington Hills
-
Contact:
- Site Public Contact
- Phone Number: 248-551-7695
-
Principal Investigator:
- Laura K. Gowans
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Helen DeVos Children's Hospital at Spectrum Health
-
Principal Investigator:
- Kathleen J. Yost
-
Contact:
- Site Public Contact
- Phone Number: 616-267-1925
- Email: crcwm-regulatory@crcwm.org
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Spectrum Health at Butterworth Campus
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Trinity Health Grand Rapids Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Kalamazoo, Michigan, United States, 49007
- Recruiting
- Bronson Methodist Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Kalamazoo, Michigan, United States, 49007
- Recruiting
- West Michigan Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Kalamazoo, Michigan, United States, 49009
- Recruiting
- Ascension Borgess Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Muskegon, Michigan, United States, 49444
- Recruiting
- Trinity Health Muskegon Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Norton Shores, Michigan, United States, 49444
- Recruiting
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Principal Investigator:
- Kathleen J. Yost
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: connie.szczepanek@crcwm.org
-
Reed City, Michigan, United States, 49677
- Recruiting
- Corewell Health Reed City Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Royal Oak, Michigan, United States, 48073
- Recruiting
- Beaumont Children's Hospital-Royal Oak
-
Contact:
- Site Public Contact
- Phone Number: 248-551-7695
-
Principal Investigator:
- Laura K. Gowans
-
Royal Oak, Michigan, United States, 48073
- Recruiting
- William Beaumont Hospital-Royal Oak
-
Contact:
- Site Public Contact
- Phone Number: 248-551-7695
-
Principal Investigator:
- Laura K. Gowans
-
Saint Joseph, Michigan, United States, 49085
- Recruiting
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Traverse City, Michigan, United States, 49684
- Recruiting
- Munson Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Troy, Michigan, United States, 48085
- Recruiting
- William Beaumont Hospital - Troy
-
Contact:
- Site Public Contact
- Phone Number: 248-551-7695
-
Principal Investigator:
- Laura K. Gowans
-
Wyoming, Michigan, United States, 49519
- Recruiting
- University of Michigan Health - West
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota/Masonic Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 612-624-2620
-
Principal Investigator:
- Peter M. Gordon
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Principal Investigator:
- Mira Kohorst
-
Contact:
- Site Public Contact
- Phone Number: 855-776-0015
-
-
Missouri
-
Chesterfield, Missouri, United States, 63017
- Recruiting
- Saint Luke's Hospital
-
Principal Investigator:
- Mark J. Fesler
-
Contact:
- Site Public Contact
- Phone Number: 314-205-6936
-
Creve Coeur, Missouri, United States, 63141
- Recruiting
- Siteman Cancer Center at West County Hospital
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy Hospitals and Clinics
-
Contact:
- Site Public Contact
- Phone Number: 816-302-6808
- Email: rryan@cmh.edu
-
Principal Investigator:
- Keith J. August
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Saint Louis, Missouri, United States, 63104
- Recruiting
- Cardinal Glennon Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 314-268-4000
-
Principal Investigator:
- William S. Ferguson
-
Saint Louis, Missouri, United States, 63141
- Recruiting
- Mercy Hospital Saint Louis
-
Contact:
- Site Public Contact
- Phone Number: 314-251-7066
-
Principal Investigator:
- Robin D. Hanson
-
Saint Louis, Missouri, United States, 63129
- Recruiting
- Siteman Cancer Center-South County
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Saint Louis, Missouri, United States, 63136
- Recruiting
- Siteman Cancer Center at Christian Hospital
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Saint Peters, Missouri, United States, 63376
- Recruiting
- Siteman Cancer Center at Saint Peters Hospital
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Children's Hospital and Medical Center of Omaha
-
Contact:
- Site Public Contact
- Phone Number: 402-955-3949
-
Principal Investigator:
- Jill C. Beck
-
Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 402-559-6941
- Email: unmcrsa@unmc.edu
-
Principal Investigator:
- Jill C. Beck
-
-
Nevada
-
Las Vegas, Nevada, United States, 89135
- Recruiting
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
Reno, Nevada, United States, 89502
- Recruiting
- Renown Regional Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
-
New Jersey
-
Elizabeth, New Jersey, United States, 07207
- Recruiting
- Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
-
Contact:
- Site Public Contact
- Phone Number: 908-994-8000
-
Principal Investigator:
- Richard A. Drachtman
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Hackensack University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 201-996-2879
-
Principal Investigator:
- Burton E. Appel
-
Jersey City, New Jersey, United States, 07302
- Recruiting
- Jersey City Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 888-823-5923
- Email: ctsucontact@westat.com
-
Principal Investigator:
- Richard A. Drachtman
-
Livingston, New Jersey, United States, 07039
- Recruiting
- Saint Barnabas Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 973-322-2934
- Email: joanne.loeb@rwjbh.org
-
Principal Investigator:
- Richard A. Drachtman
-
Long Branch, New Jersey, United States, 07740
- Recruiting
- Monmouth Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 732-923-6564
- Email: mary.danish@rwjbh.org
-
Principal Investigator:
- Richard A. Drachtman
-
Morristown, New Jersey, United States, 07960
- Recruiting
- Morristown Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 973-971-5900
-
Principal Investigator:
- Kathryn L. Laurie
-
Neptune, New Jersey, United States, 07753
- Recruiting
- Jersey Shore Medical Center
-
Principal Investigator:
- Burton E. Appel
-
Contact:
- Site Public Contact
- Phone Number: 732-776-4240
-
New Brunswick, New Jersey, United States, 08903
- Recruiting
- Rutgers Cancer Institute of New Jersey
-
Contact:
- Site Public Contact
- Phone Number: 732-235-7356
-
Principal Investigator:
- Richard A. Drachtman
-
New Brunswick, New Jersey, United States, 08903
- Recruiting
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
-
Contact:
- Site Public Contact
- Phone Number: 732-235-8675
-
Principal Investigator:
- Richard A. Drachtman
-
Newark, New Jersey, United States, 07112
- Recruiting
- Newark Beth Israel Medical Center
-
Principal Investigator:
- Richard A. Drachtman
-
Contact:
- Site Public Contact
- Phone Number: 973-926-7230
- Email: Christine.Kosmides@rwjbh.org
-
Paterson, New Jersey, United States, 07503
- Recruiting
- Saint Joseph's Regional Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 973-754-2207
- Email: HallL@sjhmc.org
-
Principal Investigator:
- Alissa Kahn
-
Toms River, New Jersey, United States, 08755
- Recruiting
- Community Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 732-557-8294
- Email: Lennette.Gonzales@rwjbh.org
-
Principal Investigator:
- Richard A. Drachtman
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102
- Recruiting
- University of New Mexico Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 505-925-0348
- Email: HSC-ClinicalTrialInfo@salud.unm.edu
-
Principal Investigator:
- Jessica M. Valdez
-
Albuquerque, New Mexico, United States, 87106
- Recruiting
- Presbyterian Hospital
-
Contact:
- Site Public Contact
- Phone Number: 505-559-6113
- Email: WBurman@phs.org
-
Principal Investigator:
- Xiaxin Li
-
-
New York
-
Albany, New York, United States, 12208
- Recruiting
- Albany Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 518-262-5513
-
Principal Investigator:
- Lauren R. Weintraub
-
Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center - Moses Campus
-
Contact:
- Site Public Contact
- Phone Number: 718-379-6866
- Email: eskwak@montefiore.org
-
Principal Investigator:
- Alice Lee
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 800-767-9355
- Email: askroswell@roswellpark.org
-
Principal Investigator:
- Kara M. Kelly
-
Mineola, New York, United States, 11501
- Recruiting
- NYU Winthrop Hospital
-
Contact:
- Site Public Contact
- Phone Number: 212-263-4432
- Email: cancertrials@nyulangone.org
-
Principal Investigator:
- Chana L. Glasser
-
New Hyde Park, New York, United States, 11040
- Recruiting
- The Steven and Alexandra Cohen Children's Medical Center of New York
-
Contact:
- Site Public Contact
- Phone Number: 718-470-3460
-
Principal Investigator:
- Arlene S. Redner
-
New York, New York, United States, 10032
- Recruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
Principal Investigator:
- Nobuko Hijiya
-
Contact:
- Site Public Contact
- Phone Number: 212-342-5162
- Email: cancerclinicaltrials@cumc.columbia.edu
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Christopher J. Forlenza
-
New York, New York, United States, 10016
- Recruiting
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Principal Investigator:
- Elizabeth A. Raetz
-
Contact:
- Site Public Contact
- Email: CancerTrials@nyulangone.org
-
New York, New York, United States, 10065
- Recruiting
- NYP/Weill Cornell Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 212-746-1848
-
Principal Investigator:
- Lisa G. Roth
-
Rochester, New York, United States, 14642
- Recruiting
- University of Rochester
-
Contact:
- Site Public Contact
- Phone Number: 585-275-5830
-
Principal Investigator:
- Paul M. Barr
-
Stony Brook, New York, United States, 11794
- Recruiting
- Stony Brook University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-862-2215
-
Principal Investigator:
- Laura E. Hogan
-
Syracuse, New York, United States, 13210
- Recruiting
- State University of New York Upstate Medical University
-
Contact:
- Site Public Contact
- Phone Number: 315-464-5476
-
Principal Investigator:
- Philip M. Monteleone
-
Webster, New York, United States, 14580
- Recruiting
- Wilmot Cancer Institute at Webster
-
Principal Investigator:
- Paul M. Barr
-
Contact:
- Site Public Contact
- Email: WCICTOresearch@urmc.rochester.edu
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- UNC Lineberger Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-668-0683
- Email: cancerclinicaltrials@med.unc.edu
-
Principal Investigator:
- Natalie S. Grover
-
Charlotte, North Carolina, United States, 28203
- Recruiting
- Carolinas Medical Center/Levine Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 800-804-9376
-
Principal Investigator:
- Joel A. Kaplan
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Medical Center
-
Principal Investigator:
- Jessica M. Sun
-
Contact:
- Site Public Contact
- Phone Number: 888-275-3853
-
Greenville, North Carolina, United States, 27834
- Recruiting
- East Carolina University
-
Contact:
- Site Public Contact
- Phone Number: 252-744-1015
- Email: eubankss@ecu.edu
-
Principal Investigator:
- Andrea R. Whitfield
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Site Public Contact
- Phone Number: 336-713-6771
-
Principal Investigator:
- Thomas W. McLean
-
-
North Dakota
-
Fargo, North Dakota, United States, 58122
- Recruiting
- Sanford Broadway Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 701-323-5760
- Email: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Principal Investigator:
- Samuel J. Milanovich
-
-
Ohio
-
Akron, Ohio, United States, 44308
- Recruiting
- Children's Hospital Medical Center of Akron
-
Contact:
- Site Public Contact
- Phone Number: 330-543-3193
-
Principal Investigator:
- Steven J. Kuerbitz
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 513-636-2799
- Email: cancer@cchmc.org
-
Principal Investigator:
- Robin E. Norris
-
Cleveland, Ohio, United States, 44106
- Recruiting
- Rainbow Babies and Childrens Hospital
-
Contact:
- Site Public Contact
- Phone Number: 216-844-5437
-
Principal Investigator:
- Duncan S. Stearns
-
Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 614-722-6039
- Email: Melinda.Triplet@nationwidechildrens.org
-
Principal Investigator:
- Mark A. Ranalli
-
Dayton, Ohio, United States, 45404
- Recruiting
- Dayton Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-228-4055
-
Principal Investigator:
- Mukund G. Dole
-
Toledo, Ohio, United States, 43606
- Recruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 419-824-1842
- Email: PCIOncResearch@promedica.org
-
Principal Investigator:
- Jamie L. Dargart
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Rene Y. McNall-Knapp
-
-
Oregon
-
Oregon City, Oregon, United States, 97045
- Recruiting
- Providence Willamette Falls Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Principal Investigator:
- Nitya Alluri
-
Portland, Oregon, United States, 97227
- Recruiting
- Legacy Emanuel Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 503-413-2560
-
Principal Investigator:
- Janice F. Olson
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
-
Contact:
- Site Public Contact
- Phone Number: 503-494-1080
- Email: trials@ohsu.edu
-
Principal Investigator:
- Bill H. Chang
-
Portland, Oregon, United States, 97213
- Recruiting
- Providence Portland Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Principal Investigator:
- Nitya Alluri
-
Portland, Oregon, United States, 97225
- Recruiting
- Providence Saint Vincent Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Principal Investigator:
- Nitya Alluri
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Recruiting
- Geisinger Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 570-271-5251
- Email: HemonCCTrials@geisinger.edu
-
Principal Investigator:
- Jagadeesh Ramdas
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
-
Contact:
- Site Public Contact
- Phone Number: 267-425-5544
- Email: CancerTrials@email.chop.edu
-
Principal Investigator:
- Leslie S. Kersun
-
Philadelphia, Pennsylvania, United States, 19134
- Recruiting
- Saint Christopher's Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 215-427-8991
-
Principal Investigator:
- Gregory E. Halligan
-
Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- Children's Hospital of Pittsburgh of UPMC
-
Contact:
- Site Public Contact
- Phone Number: 412-692-8570
- Email: jean.tersak@chp.edu
-
Principal Investigator:
- Jean M. Tersak
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
-
Contact:
- Site Public Contact
- Phone Number: 401-444-1488
-
Principal Investigator:
- Jennifer J. Welch
-
-
South Carolina
-
Boiling Springs, South Carolina, United States, 29316
- Recruiting
- Prisma Health Cancer Institute - Spartanburg
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Aniket Saha
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Contact:
- Site Public Contact
- Phone Number: 843-792-9321
- Email: hcc-clinical-trials@musc.edu
-
Principal Investigator:
- Jacqueline M. Kraveka
-
Columbia, South Carolina, United States, 29203
- Recruiting
- Prisma Health Richland Hospital
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Stuart L. Cramer
-
Greenville, South Carolina, United States, 29605
- Recruiting
- BI-LO Charities Children's Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Aniket Saha
-
Greenville, South Carolina, United States, 29601
- Recruiting
- Saint Francis Hospital
-
Contact:
- Site Public Contact
- Phone Number: 864-603-6213
- Email: melissa_beckman@bshsi.org
-
Principal Investigator:
- Howland E. Crosswell
-
Greenville, South Carolina, United States, 29607
- Recruiting
- Saint Francis Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 864-603-6213
- Email: melissa_beckman@bshsi.org
-
Principal Investigator:
- Howland E. Crosswell
-
Greenville, South Carolina, United States, 29615
- Recruiting
- Prisma Health Cancer Institute - Eastside
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Aniket Saha
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57117-5134
- Recruiting
- Sanford USD Medical Center - Sioux Falls
-
Contact:
- Site Public Contact
- Phone Number: 605-312-3320
- Email: OncologyClinicalTrialsSF@SanfordHealth.org
-
Principal Investigator:
- Kayelyn J. Wagner
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- Recruiting
- T C Thompson Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 423-778-7289
-
Principal Investigator:
- Benjamin A. Mixon
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University/Ingram Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-811-8480
-
Principal Investigator:
- Christine M. Smith
-
Nashville, Tennessee, United States, 37203
- Recruiting
- The Children's Hospital at TriStar Centennial
-
Contact:
- Site Public Contact
- Phone Number: 615-342-1919
-
Principal Investigator:
- Jennifer A. Domm
-
-
Texas
-
Austin, Texas, United States, 78723
- Recruiting
- Dell Children's Medical Center of Central Texas
-
Contact:
- Site Public Contact
- Phone Number: 512-628-1902
- Email: TXAUS-DL-SFCHemonc.research@ascension.org
-
Principal Investigator:
- Shannon M. Cohn
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern/Simmons Cancer Center-Dallas
-
Principal Investigator:
- Ksenya Shliakhtsitsava
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Dallas, Texas, United States, 75230
- Recruiting
- Medical City Dallas Hospital
-
Contact:
- Site Public Contact
- Phone Number: 972-566-5588
-
Principal Investigator:
- Stanton C. Goldman
-
El Paso, Texas, United States, 79905
- Recruiting
- El Paso Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 915-298-5444
- Email: ranjan.bista@ttuhsc.edu
-
Principal Investigator:
- Benjamin Carcamo
-
Fort Worth, Texas, United States, 76104
- Recruiting
- Cook Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 682-885-2103
- Email: CookChildrensResearch@cookchildrens.org
-
Principal Investigator:
- Karen H. Albritton
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-632-6789
- Email: askmdanderson@mdanderson.org
-
Principal Investigator:
- Najat C. Daw
-
Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 713-798-1354
- Email: burton@bcm.edu
-
Principal Investigator:
- Kala Y. Kamdar
-
Lubbock, Texas, United States, 79410
- Recruiting
- Covenant Children's Hospital
-
Principal Investigator:
- Kishor M. Bhende
-
Contact:
- Site Public Contact
- Phone Number: 806-725-8657
- Email: mbisbee@providence.org
-
Lubbock, Texas, United States, 79415
- Recruiting
- UMC Cancer Center / UMC Health System
-
Contact:
- Site Public Contact
- Phone Number: 806-775-8590
-
Principal Investigator:
- Erin K. Barr
-
San Antonio, Texas, United States, 78207
- Recruiting
- Children's Hospital of San Antonio
-
Contact:
- Site Public Contact
- Phone Number: 210-704-2894
- Email: bridget.medina@christushealth.org
-
Principal Investigator:
- Timothy C. Griffin
-
San Antonio, Texas, United States, 78229
- Recruiting
- University of Texas Health Science Center at San Antonio
-
Contact:
- Site Public Contact
- Phone Number: 210-450-3800
- Email: phoresearchoffice@uthscsa.edu
-
Principal Investigator:
- Anne-Marie R. Langevin
-
San Antonio, Texas, United States, 78229
- Recruiting
- Methodist Children's Hospital of South Texas
-
Contact:
- Site Public Contact
- Phone Number: 210-575-6240
- Email: Vinod.GidvaniDiaz@hcahealthcare.com
-
Principal Investigator:
- Jose M. Esquilin
-
-
Utah
-
Salt Lake City, Utah, United States, 84113
- Recruiting
- Primary Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 801-585-5270
-
Principal Investigator:
- Mallorie B. Heneghan
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute/University of Utah
-
Principal Investigator:
- Boyu Hu
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 434-243-6303
- Email: uvacancertrials@hscmail.mcc.virginia.edu
-
Principal Investigator:
- Brian C. Belyea
-
Falls Church, Virginia, United States, 22042
- Recruiting
- Inova Fairfax Hospital
-
Contact:
- Site Public Contact
- Phone Number: 703-208-6650
- Email: Stephanie.VanBebber@inova.org
-
Principal Investigator:
- Robin Y. Dulman
-
Norfolk, Virginia, United States, 23507
- Recruiting
- Children's Hospital of The King's Daughters
-
Contact:
- Site Public Contact
- Phone Number: 757-668-7243
- Email: CCBDCresearch@chkd.org
-
Principal Investigator:
- Eric J. Lowe
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University/Massey Cancer Center
-
Contact:
- Site Public Contact
- Email: CTOclinops@vcu.edu
-
Principal Investigator:
- Jordyn R. Griffin
-
-
Washington
-
Seattle, Washington, United States, 98105
- Recruiting
- Seattle Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 866-987-2000
-
Principal Investigator:
- Sarah E. Leary
-
Spokane, Washington, United States, 99204
- Recruiting
- Providence Sacred Heart Medical Center and Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-228-6618
- Email: HopeBeginsHere@providence.org
-
Principal Investigator:
- Judy L. Felgenhauer
-
Tacoma, Washington, United States, 98405
- Recruiting
- Mary Bridge Children's Hospital and Health Center
-
Contact:
- Site Public Contact
- Phone Number: 253-403-1461
- Email: research@multicare.org
-
Principal Investigator:
- Robert G. Irwin
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54301
- Recruiting
- Saint Vincent Hospital Cancer Center Green Bay
-
Contact:
- Site Public Contact
- Phone Number: 920-433-8889
- Email: ewd_research_admin@hshs.org
-
Principal Investigator:
- Catherine A. Long
-
La Crosse, Wisconsin, United States, 54601
- Recruiting
- Gundersen Lutheran Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 608-775-2385
- Email: cancerctr@gundersenhealth.org
-
Principal Investigator:
- Kurt Oettel
-
Madison, Wisconsin, United States, 53792
- Recruiting
- University of Wisconsin Carbone Cancer Center
-
Principal Investigator:
- Priyanka Pophali
-
Contact:
- Site Public Contact
- Phone Number: 800-622-8922
- Email: clinicaltrials@cancer.wisc.edu
-
Marshfield, Wisconsin, United States, 54449
- Recruiting
- Marshfield Medical Center-Marshfield
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Jon M. Brandt
-
Mukwonago, Wisconsin, United States, 53149
- Recruiting
- ProHealth D N Greenwald Center
-
Contact:
- Site Public Contact
- Email: research.institute@phci.org
-
Principal Investigator:
- Timothy R. Wassenaar
-
Oconomowoc, Wisconsin, United States, 53066
- Recruiting
- ProHealth Oconomowoc Memorial Hospital
-
Principal Investigator:
- Timothy R. Wassenaar
-
Contact:
- Site Public Contact
- Phone Number: 262-928-7878
-
Waukesha, Wisconsin, United States, 53188
- Recruiting
- UW Cancer Center at ProHealth Care
-
Principal Investigator:
- Timothy R. Wassenaar
-
Contact:
- Site Public Contact
- Phone Number: 262-928-5539
- Email: Chanda.miller@phci.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must be 5 to 60 years of age at the time of enrollment
- Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]) with stage I or II disease
- Patients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm)
- Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained
- Pediatric patients (age 5-17 years) must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease. Adult patients must have either a CXR or CT chest
- Patients >= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2
- Patients =< 17 years of age must have a Lansky performance score of >= 50
Pediatric patients (age 5-17 years): A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
- 2 to < 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)
- 6 to < 10 years (age): 1 mg/dL (male), 1 mg/dL (female)
- 10 to < 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)
- 13 to < 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance >= 50 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2 (within 7 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
- Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility
- For adult patients (age 18 years or older) (within 7 days prior to enrollment): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
Total bilirubin =< 2 x upper limit of normal (ULN) (within 7 days prior to enrollment)
- Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
Aspartate aminotransferase (AST) =< 3 x ULN (within 7 days prior to enrollment)
- Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
Alanine aminotransferase (ALT) =< 3 x ULN (within 7 days prior to enrollment)
- Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
- Shortening fraction of >= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 7 days prior to enrollment) or ejection fraction of >= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 7 days prior to enrollment)
- Diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 7 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of > 92% on room air
- Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Exclusion Criteria:
- Patients with nodular lymphocyte predominant Hodgkin lymphoma
- Patients with a history of active interstitial pneumonitis or interstitial lung disease
- Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
- Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills
Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to > 10 mg daily prednisone for patients >= 18 years or > 0.5 mg/kg [up to 10 mg/day] for patients < 18 years) or other immunosuppressive medications within 14 days prior to enrollment
- Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=< 10 mg daily for patients >= 18 years or =< 0.5 mg/kg [up to 10 mg/day] prednisone equivalents) are permitted in the absence of active autoimmune disease
- Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1
- Patients with peripheral neuropathy > grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
- Prior solid organ transplant
- Prior allogeneic stem cell transplantation
- Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus calmette guerin [BCG], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential
- Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment
Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of < 1% per year when used consistently and correctly) for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer
- Men and women of childbearing potential must continue contraception for a period of 6 months after last dose of brentuximab vedotin
- Women of child-bearing potential (WOCBP) must continue contraception for a period of at least 5 months after the last dose of nivolumab
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A (ABVD)
Patients receive ABVD IV for an additional 2 cycles on study.
Each cycle lasts 28 days and ABVD is administered on days 1 and 15 of each cycle.
Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or magnetic resonance imaging (MRI) throughout the trial.
Patients may also undergo blood sample collection on trial.
|
Ancillary studies
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo CT and/or PET-CT
Other Names:
Given IV
Other Names:
Undergo FDG-PET
Other Names:
Undergo MRI and/or PET-MRI
Other Names:
Undergo FDG-PET, PET, PET-CT, and/or PET-MRI
Other Names:
|
Experimental: Arm B (ABVD, brentuximab vedotin, nivolumab)
Patients receive brentuximab vedotin IV and nivolumab IV once during each treatment cycle.
Each cycle lasts 21 days.
Treatment continues for 4 cycles.
Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial.
Patients may also undergo blood sample collection on trial.
|
Given IV
Other Names:
Ancillary studies
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo CT and/or PET-CT
Other Names:
Given IV
Other Names:
Undergo FDG-PET
Other Names:
Undergo MRI and/or PET-MRI
Other Names:
Undergo FDG-PET, PET, PET-CT, and/or PET-MRI
Other Names:
|
Experimental: Arm C (ABVD, eBEACOPP, ISRT)
Patients receive eBEACOPP regimen (doxorubicin hydrochloride IV on day 1, cyclophosphamide IV on day 1, etoposide or etoposide phosphate IV on days 1-3, prednisone or prednisolone orally [PO] daily for the first 14 days of each treatment cycle, procarbazine hydrochloride PO on days 1-7, bleomycin sulfate IV on day 8, and vincristine sulfate IV) on day 8 of each treatment cycle.
Treatment continues for 2 cycles.
Each cycle lasts 21 days.
Subsequently, patients undergo ISRT.
Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial.
Patients may also undergo blood sample collection on trial.
|
Given IV
Other Names:
Ancillary studies
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Undergo CT and/or PET-CT
Other Names:
Given IV
Other Names:
Undergo FDG-PET
Other Names:
Undergo MRI and/or PET-MRI
Other Names:
Undergo FDG-PET, PET, PET-CT, and/or PET-MRI
Other Names:
Undergo ISRT
Other Names:
Given PO
Other Names:
|
Experimental: Arm D (ABVD, brentuximab vedotin, nivolumab, ISRT)
Patients receive brentuximab vedotin IV and nivolumab IV as in arm B followed by ISRT.
Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial.
Patients may also undergo blood sample collection on trial.
|
Given IV
Other Names:
Ancillary studies
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo CT and/or PET-CT
Other Names:
Given IV
Other Names:
Undergo FDG-PET
Other Names:
Undergo MRI and/or PET-MRI
Other Names:
Undergo FDG-PET, PET, PET-CT, and/or PET-MRI
Other Names:
Undergo ISRT
Other Names:
|
Experimental: Arm E (ABVD, AVD)
Patients receive AVD regimen (doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV) on days 1 and 15 of each treatment cycle.
Each cycle lasts 28 days.
Treatment continues for 4 cycles.
Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial.
Patients may also undergo blood sample collection on trial.
|
Ancillary studies
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo CT and/or PET-CT
Other Names:
Given IV
Other Names:
Undergo FDG-PET
Other Names:
Undergo MRI and/or PET-MRI
Other Names:
Undergo FDG-PET, PET, PET-CT, and/or PET-MRI
Other Names:
|
Experimental: Arm F (ABVD, brentuximab vedotin, nivolumab)
Patients receive treatment as in arm B. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial.
Patients may also undergo blood sample collection on trial.
|
Given IV
Other Names:
Ancillary studies
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo CT and/or PET-CT
Other Names:
Given IV
Other Names:
Undergo FDG-PET
Other Names:
Undergo MRI and/or PET-MRI
Other Names:
Undergo FDG-PET, PET, PET-CT, and/or PET-MRI
Other Names:
|
Experimental: Arm G (ABVD, eBEACOPP, ISRT)
Patients receive treatment and imaging, and may undergo blood sample collection as in arm C.
|
Given IV
Other Names:
Ancillary studies
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Undergo CT and/or PET-CT
Other Names:
Given IV
Other Names:
Undergo FDG-PET
Other Names:
Undergo MRI and/or PET-MRI
Other Names:
Undergo FDG-PET, PET, PET-CT, and/or PET-MRI
Other Names:
Undergo ISRT
Other Names:
Given PO
Other Names:
|
Experimental: Arm H (ABVD, brentuximab vedotin, nivolumab, ISRT)
Patients receive treatment and imaging, and may undergo blood sample collection as in arm D.
|
Given IV
Other Names:
Ancillary studies
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo CT and/or PET-CT
Other Names:
Given IV
Other Names:
Undergo FDG-PET
Other Names:
Undergo MRI and/or PET-MRI
Other Names:
Undergo FDG-PET, PET, PET-CT, and/or PET-MRI
Other Names:
Undergo ISRT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) in rapid early responder (RER) patients
Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years after the randomization of the last patient or when reaching 230 events, whichever comes first
|
Will compare PFS of the immunotherapy (IO) therapy to that of the standard therapy in RER patients.
PFS curves will be estimated using Kaplan Meier approach.
Primary analyses will be based on 1-sided log-rank test comparisons of PFS curves between the 2 randomized arms per intention-to-treat principle.
|
Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years after the randomization of the last patient or when reaching 230 events, whichever comes first
|
PFS in slow-early responder (SER) patients
Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years after the randomization of the last patient or when reaching 116 events, whichever comes first
|
Will compare PFS of the IO therapy and involved site radiation therapy (ISRT) to that of the standard therapy and ISRT in SER patients.
PFS curves will be estimated using Kaplan Meier approach.
Primary analyses will be based on 1-sided log-rank test comparisons of PFS curves between the 2 randomized arms per intention-to-treat principle.
|
Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years after the randomization of the last patient or when reaching 116 events, whichever comes first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS for favorable risk patients
Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years
|
3-year PFS and corresponding confidence interval will be estimated using the Kaplan-Meier approach.
Meanwhile, the 3-year PFS will also be compared between the IO therapy and the standard therapy cohorts with the log-rank test.
|
Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years
|
Patient-reported fatigue
Time Frame: At baseline, during chemotherapy (cycle 2, day 1), at completion of therapy (time 0 of follow up) and at 1 and 4 years post completion of therapy
|
Will be measured by validated short forms from the Patient Reported Outcomes Measurement Information System initiative.
Domain scores will be converted to T-scores with an established standard deviation of 10 points with an average score normalized to 50 within the healthy adult population.
The minimal clinically important difference (MCID) in these PRO measures has been accepted to be 2-3 points of the standard deviation ([SD] = 10) of the measure.
To account for the dual primary PRO outcomes of fatigue, will consider Bonferroni correction family-wise p-value for overall difference evaluation.
Primary interests will be differences in T-scores between immunotherapy and chemotherapy arms at 1-year post completion of therapy.
|
At baseline, during chemotherapy (cycle 2, day 1), at completion of therapy (time 0 of follow up) and at 1 and 4 years post completion of therapy
|
Patient-reported cognitive deficits
Time Frame: At baseline, during chemotherapy (cycle 2, day 1), at completion of therapy (time 0 of follow up) and at 1 and 4 years post completion of therapy
|
Will be measured by validated short form, Quality of Life in Neurological Disorders initiatives.
Domain scores will be converted to T-scores with an established standard deviation of 10 points with an average score normalized to 50 within the healthy adult population.
The MCID in these PRO measures has been accepted to be 2-3 points of the standard deviation (SD = 10) of the measure.
To account for the dual primary PRO outcomes of cognitive deficits, will consider Bonferroni correction family-wise p-value for overall difference evaluation.
Primary interests will be differences in T-scores between immunotherapy and chemotherapy arms at 1-year post completion of therapy.
|
At baseline, during chemotherapy (cycle 2, day 1), at completion of therapy (time 0 of follow up) and at 1 and 4 years post completion of therapy
|
Overall survival (OS) in RER patients
Time Frame: Time of randomization to death, assessed up to 12 years after the last enrollment
|
Will compare OS in IO therapy to standard therapy in RER patients.
OS will be determined by positron emission tomography (PET)/computed tomography (CT) and compared using a 1-sided log-rank test.
The analysis will be conducted based on confidence interval (CI) approach at 12 years after the last enrollment.
The 12-year OS and corresponding confidence interval will be estimated with Kaplan-Meier method for each study arm.
|
Time of randomization to death, assessed up to 12 years after the last enrollment
|
OS in SER patients
Time Frame: Time of randomization to death, assessed up to 12 years after the last enrollment
|
Will compare OS in IO therapy and ISRT to standard therapy and ISRT in SER patients.
OS will be determined by PET/CT and compared using a 1-sided log-rank test.
The analysis will be conducted based on CI approach at 12 years after the last enrollment.
The 12-year OS and corresponding confidence interval will be estimated with Kaplan-Meier method for each study arm.
|
Time of randomization to death, assessed up to 12 years after the last enrollment
|
OS for entire patient population
Time Frame: At 12 years after the last enrollment
|
Comparison will be conducted using 1-sided log-rank tests.
The 12-year OS and corresponding CI will be estimated with Kaplan-Meier method.
|
At 12 years after the last enrollment
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PFS for unfavorable risk patients
Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years from last enrollment
|
3-year PFS and corresponding confidence interval will be estimated using the Kaplan-Meier approach.
Meanwhile, the 3-year PFS will also be compared between the IO therapy and the standard therapy cohorts with the log-rank test.
|
Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years from last enrollment
|
PFS for entire population
Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years from last enrollment
|
3-year PFS and corresponding confidence interval will be estimated using the Kaplan-Meier approach.
Meanwhile, the 3-year PFS will also be compared between the IO therapy and the standard therapy cohorts with the log-rank test.
|
Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years from last enrollment
|
Event-free survival (EFS)
Time Frame: Time from randomization to the first event (disease progression, relapse, subsequent malignant neoplasms, or death), assessed up to 12 years from last enrollment
|
12-year EFS and corresponding confidence interval will be estimated with Kaplan-Meier approach for patients with and without radiation therapy (RT) under each treatment arm (standard chemotherapy and IO therapy).
Meanwhile the EFS curves will be compared between patients with and without RT for each of the treatment arm with log-rank test.
|
Time from randomization to the first event (disease progression, relapse, subsequent malignant neoplasms, or death), assessed up to 12 years from last enrollment
|
Incidence of adverse events (AEs)
Time Frame: Assessed up to 12 years from last enrollment
|
Will use the American Society of Clinical Oncology and the Society for Immunotherapy of Cancer guidelines to capture immune-related adverse events.
Physician-reported treatment related adverse events will be reported for all grades using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Comparison of toxicities with grades greater or equal to 3 will be conducted between the arms using Fisher's exact test.
The maximum grade for each toxicity will be recorded for each patient.
The averages and confidence intervals for these toxicity frequencies will be provided.
Comparison of AEs will also be conducted for physician-reported treatment-related adverse events between RT and non-RT patients.
|
Assessed up to 12 years from last enrollment
|
Patient reported outcomes (PROs)
Time Frame: Assessed up to 12 years from last enrollment
|
PROs will be assessed using the PRO-CTCAE for patients 17 and older.
The pediatric (Ped)-PRO-CTCAE will be used for patients aged 7-17 and the PRO-CTCAE will be used for those 18 and older.
the scores for each attribute together with frequency, severity and/or interference will be presented descriptively using summary statistics at each assessment time.
Additionally, the worst severity and/or interference over the entire course will be summarized.
The changes among main time points will be calculated.
Regression models based on longitudinal measurements can be constructed by considering the following covariates besides age groups: baseline demographics, clinical risk factors, and study arms.
Comparisons of PRO CTCAE will also be conducted between RT and non-RT patients.
|
Assessed up to 12 years from last enrollment
|
Patient-reported health-related quality of life
Time Frame: At baseline, during chemotherapy (cycle 2, day 1), at completion of therapy (time 0 of follow up) and at 1 and 4 years post completion of therapy
|
At baseline, during chemotherapy (cycle 2, day 1), at completion of therapy (time 0 of follow up) and at 1 and 4 years post completion of therapy
|
|
Incidence of self-reported late morbidities
Time Frame: Assessed up to 12 years from last enrollment
|
Will be collected by using validated measures from the St. Jude Life Cohort.
The cumulative incidence of late-morbidities (e.g., cardiovascular, pulmonary and endocrine) will be compared between the standard chemotherapy and the IO therapy and among different age groups (7-14; 15-40 and 41-60) with K-sample method.
The frequencies of selected organ toxicities will be compared between two treatment arms, among the three age groups and between RT and non-RT with chi-square tests.
|
Assessed up to 12 years from last enrollment
|
Effect of metabolic tumor burden (MTV) on PFS
Time Frame: At baseline prior to initiation of therapy
|
MTV will be measured at baseline using fludeoxyglucose F-18 (FDG)-PET.
The Kaplan-Meier curves of PFS will be compared between the two levels with log-rank tests.
|
At baseline prior to initiation of therapy
|
Effect of total lesion glycolysis (TLG) on PFS
Time Frame: At baseline prior to initiation of therapy
|
TLG will be measured at baseline using FDG-PET.
The Kaplan-Meier curves of PFS will be compared between the two levels with log-rank tests.
|
At baseline prior to initiation of therapy
|
Contribution of social determinants of health (SDOH) to initial response to therapy by race/ethnicity
Time Frame: Assessed post cycle 2
|
Assessed post cycle 2
|
|
Contribution of SDOH to PFS by race/ethnicity
Time Frame: Assessed up to 12 years after last enrollment
|
Kaplan-Meier (K-M) curves of PFS will be generated by racial/ethnic groups.
The p values for the K-M curve comparison will be provided via log-rank test.
Life tables will provide the PFS over the follow-up years.
Associations between race/ethnicity and survival outcomes (PFS) will be evaluated with univariable and multivariable Cox proportional hazard models by considering other covariates such as baseline clinical conditions, toxicities and up-front therapy (conventional versus IO).
Backward selection will be used to select those factors with p-value < 0.2, which will be included in final multivariable models.
|
Assessed up to 12 years after last enrollment
|
Contribution of SDOH to OS by race/ethnicity
Time Frame: Assessed up to 12 years after last enrollment
|
Kaplan-Meier curves of OS will be generated by racial/ethnic groups.
The p values for the K-M curve comparison will be provided via log-rank test.
Life tables will provide the OS over the follow-up years.
Associations between race/ethnicity and survival outcomes (OS) will be evaluated with univariable and multivariable Cox proportional hazard models by considering other covariates such as baseline clinical conditions, SDOH, toxicities and up-front therapy (conventional versus IO).
Backward selection will be used to select those factors with p-value < 0.2, which will be included in final multivariable models.
|
Assessed up to 12 years after last enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS comparison between treatment arms for each age group
Time Frame: At 3 years
|
Will be compared between a standard chemotherapy approach and an IO therapy approach stratified by different age groups (ages 5-11 years, 12-21 years, 22-39 years, 40-60 years) with log-rank test.
Cox regression model will be constructed to evaluate the treatment effects for different age groups by considering all other significant including baseline demographics and clinical risk factors.
The 3-year PFS and corresponding confidence interval for each age group and each treatment arm will be provided with Kaplan-Meier method.
|
At 3 years
|
Association between FDG PET parameters obtained by automated measurements and PFS
Time Frame: At baseline, post cycle 2, and at the end of therapy
|
The association between FDG PET parameters obtained by automated measurements using convolutional neural networks and PFS will be evaluated in this aim.
The PET parameters of interest are total MTV and TLG, tumor standardized uptake value change.
PET parameters will be obtained based on artificial intelligence (AI) based measurements.
The effect of these PET measurements will be evaluated by Cox regression models.
|
At baseline, post cycle 2, and at the end of therapy
|
Agreement between AI derived FDG-PET measurement extraction and physician-based manual quantitative PET measurement
Time Frame: At baseline, post cycle 2, and at the end of therapy
|
Will compare AI derived automated quantitative FDG-PET measurement extraction and physician-based manual quantitative PET measurement with Spearman rank correlation coefficients for each extracted PET metric.
|
At baseline, post cycle 2, and at the end of therapy
|
Post-relapse/post-progression overall survival by race/ethnicity and select SDOH measures
Time Frame: Assessed up to 12 years
|
The K-M curves will be presented together with p-values via log-rank tests across the different race/ethnicity groups for each treatment arm.
Cox proportional hazard models to evaluate the relationship between race/ethnicity and post-relapse OS will be constructed.
|
Assessed up to 12 years
|
Completion rate of PRO and health-related quality of life contact forms
Time Frame: At 1 year off treatment
|
Will be evaluated for the first 450 eligible participants.
|
At 1 year off treatment
|
Concordance and discordance of 5-point score (PS) visual PET assessments
Time Frame: At baseline, post cycle 2, and at end of systemic therapy
|
The concordance and discordance of 5-PS visual PET assessment from rapid central review and local institutional review will be evaluated at each of the timepoints.
Will collect and retrospectively review local versus central review concordance rates.
For discordant cases, will document the differences in treatments if only local review or only central review were performed
|
At baseline, post cycle 2, and at end of systemic therapy
|
Incidence of patient reported adverse events and provider adverse event reporting
Time Frame: Assessed up to 12 years
|
Will be collected by PRO-CTCAE and Ped-PRO-CTCAE.
The patient reported adverse events will be compared to provider reported adverse events.
The descriptive statistics will be reported, and frequencies will be compared with chi-square tests.
|
Assessed up to 12 years
|
Association between self-reported race/ethnicity and dimensional SDOH
Time Frame: Assessed up to 12 years
|
Will be evaluated by chi-square tests.
Will also calculate the area deprivation index (derived from patient-reported address and zip code to census block-group data for patients treated in the United States, and the Canadian Index of Multiple Deprivation for patients treated in Canada) and investigate its association with race/ethnicity and SDOH.
|
Assessed up to 12 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tara O Henderson, Children's Oncology Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Radiopharmaceuticals
- Antibiotics, Antineoplastic
- Immune Checkpoint Inhibitors
- Keratolytic Agents
- Immunotoxins
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Cyclophosphamide
- Etoposide
- Etoposide phosphate
- Fluorodeoxyglucose F18
- Antibodies
- Nivolumab
- Podophyllotoxin
- Immunoglobulins
- Prednisone
- Doxorubicin
- Liposomal doxorubicin
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Vincristine
- Dacarbazine
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
- Cortisone
- Bleomycin
- Brentuximab Vedotin
- Vinblastine
- Immunoconjugates
- Imidazole
- Procarbazine
- Deoxyglucose
Other Study ID Numbers
- NCI-2022-10845 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180886 (U.S. NIH Grant/Contract)
- AHOD2131 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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