Nivolumabi yhdistelmänä kemoimmunoterapian kanssa vasta diagnosoidun primaarisen välikarsinan B-solulymfooman hoitoon
Satunnaistettu vaiheen 3 koe nivolumabista (NSC# 748726) yhdistettynä kemoimmunoterapian kanssa äskettäin diagnosoidun primaarisen välikarsinan B-solulymfooman hoitoon
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
- Lääke: Cyclophosphamide
- Lääke: Doxorubicin Hydrochloride
- Lääke: Prednisone
- Biologinen: Rituximab
- Lääke: Vincristine Sulfate
- Menettely: Echocardiography Test
- Biologinen: Nivolumab
- Menettely: Computed Tomography
- Menettely: Positron Emission Tomography
- Lääke: Etoposide Phosphate
- Biologinen: Filgrastim
- Menettely: Bone Marrow Aspiration
- Menettely: Bone Marrow Biopsy
- Säteily: Radiation Therapy
- Lääke: Prednisolone
- Biologinen: Pegfilgrastim
- Menettely: Lumbar Puncture
- Menettely: Biospecimen Collection
- Biologinen: Rituximab and Hyaluronidase Human
Yksityiskohtainen kuvaus
PRIMARY OBJECTIVE:
I. To determine if nivolumab + chemo-immunotherapy results in a superior long term progression-free survival (PFS) (events defined as disease progression confirmed by central review or death) when compared with chemo-immunotherapy alone in patients with newly diagnosed primary mediastinal B-cell lymphoma.
SECONDARY OBJECTIVES:
I. To compare the rates of "efficacy-related event-free survival (EFS)" (eEFS) (events defined as progression, change in therapy due to finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, or death) between chemo-immunotherapy alone and chemo-immunotherapy + nivolumab in patients with newly diagnosed PMBCL.
II. To compare the rates of "therapy-related EFS" (tEFS) (events defined as relapse/progression, change in therapy for any reason, biopsy + disease after 6 cycles of therapy, secondary malignancy [SMN] or death) between chemo-immunotherapy alone and chemo-immunotherapy + nivolumab in patients with newly diagnosed PMBCL.
III. To compare the rates of overall survival (OS) between chemo-immunotherapy alone and chemo-immunotherapy + nivolumab in patients with newly diagnosed PMBCL.
IV. To establish the rate of a positive positron emission tomography (PET)-computed tomography (CT) (defined as Deauville score 4 or 5) at the completion of 6 cycles of nivolumab + rituximab (R)- cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)/dose-adjusted (DA)-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH)-R and R-CHOP/DA-EPOCH-R in patients with newly diagnosed PMBCL and evaluate the prognostic significance of such a finding.
EXPLORATORY OBJECTIVES:
I. To bank radiology images for further studies. II. To bank specimens for future correlative studies. III. Characterize the immune profile of patients treated with nivolumab + chemo-immunotherapy to identify markers predictive of response.
IV. Define the rate of complete response at the completion of initial planned therapy.
OUTLINE: Patients are randomly assigned to backbone therapy or backbone therapy + nivolumab within each of 6 strata. The strata are determined by physician's choice of backbone (DA-EPOCH-R versus [vs.] R-CHOP vs. R-CHOP + RT) and whether or not the patient had 1 prior cycle of therapy.
ARM A (DA-EPOCH-R): Patients receive prednisone or prednisolone orally (PO) once daily (QD) on days 1-5 and rituximab intravenously (IV) or rituximab and hyaluronidase human subcutaneously (SC) over 5 minutes on day 1 or 5. Patients also receive etoposide phosphate, doxorubicin hydrochloride, and vincristine sulfate IV over 96 hours on days 1-4 and cyclophosphamide IV over 30-60 minutes on day 5. Beginning 24-72 hours after completing cyclophosphamide, patients receive filgrastim or pegylated filgrastim SC daily until absolute neutrophil count (ANC) is >= 500/uL after the expected nadir. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) during screening and as clinically indicated and a lumbar puncture (LP) for cerebral spinal fluid (CSF) collection optionally during screening. Patients also undergo computed tomography (CT) or positron emission tomography (PET)/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
ARM B (DA-EPOCH-R + NIVOLUMAB): Patients receive treatment as in Arm A. Patients also receive nivolumab IV over 30 minutes on day 1. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
ARM C (R-CHOP): Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV over 1-15 minutes or up to 60 minutes, and vincristine sulfate IV over 1 or up to 60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
ARM D (R-CHOP + NIVOLUMAB): Patients receive treatment as in Arm C. Patients also receive nivolumab IV over 30 minutes on day 1. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
ARM E (R-CHOP + RADIOTHERAPY): Patients receive treatment as in Arm C. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
ARM F (R-CHOP + RADIOTHERAPY + NIVOLUMAB): Patients receive treatment as in Arm D. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
After completion of study treatment, patients are followed up every 3 months for year 1, every 6 months for years 2-3, and annually thereafter.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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New South Wales
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Hunter Regional Mail Centre, New South Wales, Australia, 2310
- John Hunter Children's Hospital
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Westmead, New South Wales, Australia, 2145
- The Children's Hospital at Westmead
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Queensland Children's Hospital
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6009
- Perth Children's Hospital
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-
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Québec, Kanada, G1V 4G2
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
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Alberta
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Edmonton, Alberta, Kanada, T6G 2B7
- University of Alberta Hospital
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Manitoba
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Winnipeg, Manitoba, Kanada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
- Janeway Child Health Centre
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Kanada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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London, Ontario, Kanada, N6A 5W9
- Children's Hospital
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Ottawa, Ontario, Kanada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Kanada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Kanada, H3H 1P3
- The Montreal Children's Hospital of the MUHC
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Montreal, Quebec, Kanada, H3T 1C5
- Centre Hospitalier Universitaire Sainte-Justine
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Sherbrooke, Quebec, Kanada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
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-
-
-
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Caguas, Puerto Rico, 00726
- HIMA San Pablo Oncologic Hospital
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-
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Alabama
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Birmingham, Alabama, Yhdysvallat, 35233
- Children's Hospital of Alabama
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Mobile, Alabama, Yhdysvallat, 36604
- USA Health Strada Patient Care Center
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Alaska
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Anchorage, Alaska, Yhdysvallat, 99508
- Providence Alaska Medical Center
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Arizona
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Mesa, Arizona, Yhdysvallat, 85202
- Banner Children's at Desert
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Tucson, Arizona, Yhdysvallat, 85719
- Banner University Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Yhdysvallat, 72202-3591
- Arkansas Children's Hospital
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California
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Costa Mesa, California, Yhdysvallat, 92627
- UC Irvine Health Cancer Center-Newport
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Downey, California, Yhdysvallat, 90242
- Kaiser Permanente Downey Medical Center
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Duarte, California, Yhdysvallat, 91010
- City of Hope Comprehensive Cancer Center
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Irvine, California, Yhdysvallat, 92618
- City of Hope at Irvine Lennar
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Irvine, California, Yhdysvallat, 92612
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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Loma Linda, California, Yhdysvallat, 92354
- Loma Linda University Medical Center
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Long Beach, California, Yhdysvallat, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, Yhdysvallat, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Yhdysvallat, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, Yhdysvallat, 90095
- Mattel Children's Hospital UCLA
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Madera, California, Yhdysvallat, 93636
- Valley Children's Hospital
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Oakland, California, Yhdysvallat, 94611
- Kaiser Permanente-Oakland
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Orange, California, Yhdysvallat, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Orange, California, Yhdysvallat, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Yhdysvallat, 94304
- Lucile Packard Children's Hospital Stanford University
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Sacramento, California, Yhdysvallat, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, Yhdysvallat, 92123
- Rady Children's Hospital - San Diego
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Colorado
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Aurora, Colorado, Yhdysvallat, 80045
- Children's Hospital Colorado
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Denver, Colorado, Yhdysvallat, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Connecticut
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Hartford, Connecticut, Yhdysvallat, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, Yhdysvallat, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington D.C., District of Columbia, Yhdysvallat, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, Yhdysvallat, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Lauderdale, Florida, Yhdysvallat, 33316
- Broward Health Medical Center
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Fort Myers, Florida, Yhdysvallat, 33908
- Golisano Children's Hospital of Southwest Florida
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Gainesville, Florida, Yhdysvallat, 32610
- UF Health Cancer Institute - Gainesville
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Hollywood, Florida, Yhdysvallat, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, Yhdysvallat, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, Yhdysvallat, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orlando, Florida, Yhdysvallat, 32827
- Nemours Children's Hospital
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Orlando, Florida, Yhdysvallat, 32806
- Arnold Palmer Hospital for Children
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St. Petersburg, Florida, Yhdysvallat, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, Yhdysvallat, 33606
- Tampa General Hospital
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Tampa, Florida, Yhdysvallat, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Yhdysvallat, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Yhdysvallat, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Yhdysvallat, 30308
- Emory Proton Therapy Center
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Atlanta, Georgia, Yhdysvallat, 30329
- Children's Healthcare of Atlanta - Arthur M Blank Hospital
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Savannah, Georgia, Yhdysvallat, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Yhdysvallat, 96826
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, Yhdysvallat, 83712
- Saint Luke's Cancer Institute - Boise
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Illinois
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Aurora, Illinois, Yhdysvallat, 60504
- Rush-Copley Medical Center
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Chicago, Illinois, Yhdysvallat, 60611
- Northwestern University
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Chicago, Illinois, Yhdysvallat, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Yhdysvallat, 60612
- University of Illinois
-
Chicago, Illinois, Yhdysvallat, 60611
- Lurie Children's Hospital-Chicago
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Danville, Illinois, Yhdysvallat, 61832
- Carle at The Riverfront
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DeKalb, Illinois, Yhdysvallat, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Yhdysvallat, 62526
- Decatur Memorial Hospital
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Effingham, Illinois, Yhdysvallat, 62401
- Carle Physician Group-Effingham
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Geneva, Illinois, Yhdysvallat, 60134
- Northwestern Medicine Cancer Center Delnor
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Lake Forest, Illinois, Yhdysvallat, 60045
- Northwestern Medicine Lake Forest Hospital
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Mattoon, Illinois, Yhdysvallat, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Yhdysvallat, 60153
- Loyola University Medical Center
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O'Fallon, Illinois, Yhdysvallat, 62269
- HSHS Saint Elizabeth's Hospital
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Oak Lawn, Illinois, Yhdysvallat, 60453
- Advocate Children's Hospital-Oak Lawn
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Park Ridge, Illinois, Yhdysvallat, 60068
- Advocate Children's Hospital-Park Ridge
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Peoria, Illinois, Yhdysvallat, 61637
- OSF Children's Hospital of Illinois
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Springfield, Illinois, Yhdysvallat, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Yhdysvallat, 62702
- Springfield Clinic
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Springfield, Illinois, Yhdysvallat, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Yhdysvallat, 61801
- Carle Cancer Center
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Warrenville, Illinois, Yhdysvallat, 60555
- Northwestern Medicine Cancer Center Warrenville
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Indiana
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Indianapolis, Indiana, Yhdysvallat, 46202
- Riley Hospital for Children
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Richmond, Indiana, Yhdysvallat, 47374
- Reid Health
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Iowa
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Ankeny, Iowa, Yhdysvallat, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Clive, Iowa, Yhdysvallat, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Yhdysvallat, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Yhdysvallat, 50309
- Blank Children's Hospital
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Des Moines, Iowa, Yhdysvallat, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Iowa City, Iowa, Yhdysvallat, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Sioux City, Iowa, Yhdysvallat, 51101
- Siouxland Regional Cancer Center
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Waukee, Iowa, Yhdysvallat, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Kansas
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Wichita, Kansas, Yhdysvallat, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, Yhdysvallat, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, Yhdysvallat, 40202
- Norton Children's Hospital
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Louisiana
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New Orleans, Louisiana, Yhdysvallat, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, Yhdysvallat, 70118
- Children's Hospital New Orleans
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Maine
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Bangor, Maine, Yhdysvallat, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, Yhdysvallat, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, Yhdysvallat, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Yhdysvallat, 21204
- Greater Baltimore Medical Center
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Baltimore, Maryland, Yhdysvallat, 21201
- University of Maryland/Greenebaum Cancer Center
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Bethesda, Maryland, Yhdysvallat, 20889-5600
- Walter Reed National Military Medical Center
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Yhdysvallat, 02111
- Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48109
- C S Mott Children's Hospital
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Detroit, Michigan, Yhdysvallat, 48202
- Henry Ford Hospital
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Detroit, Michigan, Yhdysvallat, 48201
- Children's Hospital of Michigan
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East Lansing, Michigan, Yhdysvallat, 48823
- Michigan State University
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Grand Rapids, Michigan, Yhdysvallat, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Kalamazoo, Michigan, Yhdysvallat, 49007
- Bronson Methodist Hospital
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Niles, Michigan, Yhdysvallat, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Royal Oak, Michigan, Yhdysvallat, 48073
- Corewell Health Children's
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Minnesota
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Burnsville, Minnesota, Yhdysvallat, 55337
- Minnesota Oncology - Burnsville
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Coon Rapids, Minnesota, Yhdysvallat, 55433
- Mercy Hospital
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Edina, Minnesota, Yhdysvallat, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Yhdysvallat, 55432
- Unity Hospital
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Maplewood, Minnesota, Yhdysvallat, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Yhdysvallat, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Yhdysvallat, 55407
- Abbott-Northwestern Hospital
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Saint Louis Park, Minnesota, Yhdysvallat, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Yhdysvallat, 55102
- United Hospital
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Mississippi
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Jackson, Mississippi, Yhdysvallat, 39216
- University of Mississippi Medical Center
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Missouri
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Chesterfield, Missouri, Yhdysvallat, 63017
- Saint Luke's Hospital
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City of Saint Peters, Missouri, Yhdysvallat, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Yhdysvallat, 63141
- Siteman Cancer Center at West County Hospital
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Kansas City, Missouri, Yhdysvallat, 64108
- Children's Mercy Hospitals and Clinics
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St Louis, Missouri, Yhdysvallat, 63110
- Washington University School of Medicine
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St Louis, Missouri, Yhdysvallat, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Yhdysvallat, 63136
- Siteman Cancer Center at Christian Hospital
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St Louis, Missouri, Yhdysvallat, 63141
- Mercy Hospital Saint Louis
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, Yhdysvallat, 68114
- Children's Hospital and Medical Center of Omaha
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Nevada
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Las Vegas, Nevada, Yhdysvallat, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Reno, Nevada, Yhdysvallat, 89502
- Renown Regional Medical Center
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New Hampshire
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Lebanon, New Hampshire, Yhdysvallat, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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New Jersey
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Basking Ridge, New Jersey, Yhdysvallat, 07920
- Memorial Sloan Kettering Basking Ridge
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Hackensack, New Jersey, Yhdysvallat, 07601
- Hackensack University Medical Center
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Middletown, New Jersey, Yhdysvallat, 07748
- Memorial Sloan Kettering Monmouth
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Montvale, New Jersey, Yhdysvallat, 07645
- Memorial Sloan Kettering Bergen
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Morristown, New Jersey, Yhdysvallat, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, Yhdysvallat, 08903
- Rutgers Cancer Institute of New Jersey
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New Brunswick, New Jersey, Yhdysvallat, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Paterson, New Jersey, Yhdysvallat, 07503
- Saint Joseph's Regional Medical Center
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-
New Mexico
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Albuquerque, New Mexico, Yhdysvallat, 87106
- Presbyterian Hospital
-
-
New York
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Albany, New York, Yhdysvallat, 12208
- Albany Medical Center
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Buffalo, New York, Yhdysvallat, 14263
- Roswell Park Cancer Institute
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Commack, New York, Yhdysvallat, 11725
- Memorial Sloan Kettering Commack
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Harrison, New York, Yhdysvallat, 10604
- Memorial Sloan Kettering Westchester
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New Hyde Park, New York, Yhdysvallat, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
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New York, New York, Yhdysvallat, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, Yhdysvallat, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, Yhdysvallat, 10065
- NYP/Weill Cornell Medical Center
-
Rochester, New York, Yhdysvallat, 14642
- University of Rochester
-
Stony Brook, New York, Yhdysvallat, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Yhdysvallat, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Yhdysvallat, 10467
- Montefiore Medical Center - Moses Campus
-
Uniondale, New York, Yhdysvallat, 11553
- Memorial Sloan Kettering Nassau
-
Valhalla, New York, Yhdysvallat, 10595
- New York Medical College
-
Webster, New York, Yhdysvallat, 14580
- Wilmot Cancer Institute at Webster
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North Carolina
-
Asheville, North Carolina, Yhdysvallat, 28801
- Mission Hospital
-
Asheville, North Carolina, Yhdysvallat, 28803
- AdventHealth Infusion Center Asheville
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Charlotte, North Carolina, Yhdysvallat, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, Yhdysvallat, 28204
- Novant Health Presbyterian Medical Center
-
Greenville, North Carolina, Yhdysvallat, 27834
- East Carolina University
-
Hendersonville, North Carolina, Yhdysvallat, 28792
- AdventHealth Hendersonville
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Winston-Salem, North Carolina, Yhdysvallat, 27157
- Wake Forest University Health Sciences
-
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North Dakota
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Fargo, North Dakota, Yhdysvallat, 58122
- Sanford Broadway Medical Center
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-
Ohio
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Akron, Ohio, Yhdysvallat, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Yhdysvallat, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Yhdysvallat, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Yhdysvallat, 44106
- Rainbow Babies and Childrens Hospital
-
Columbus, Ohio, Yhdysvallat, 43205
- Nationwide Children's Hospital
-
Dayton, Ohio, Yhdysvallat, 45404
- Dayton Children's Hospital
-
Dayton, Ohio, Yhdysvallat, 45415
- Dayton Physician LLC - Englewood
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Kettering, Ohio, Yhdysvallat, 45429
- Kettering Medical Center
-
Kettering, Ohio, Yhdysvallat, 45409
- Greater Dayton Cancer Center
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Toledo, Ohio, Yhdysvallat, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
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Oklahoma
-
Oklahoma City, Oklahoma, Yhdysvallat, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
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Portland, Oregon, Yhdysvallat, 97239
- Oregon Health and Science University
-
Portland, Oregon, Yhdysvallat, 97227
- Legacy Emanuel Children's Hospital
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-
Pennsylvania
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Allentown, Pennsylvania, Yhdysvallat, 18103
- Lehigh Valley Hospital-Cedar Crest
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Danville, Pennsylvania, Yhdysvallat, 17822
- Geisinger Medical Center
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Hershey, Pennsylvania, Yhdysvallat, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Yhdysvallat, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Yhdysvallat, 19134
- Saint Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Yhdysvallat, 15224
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
-
Providence, Rhode Island, Yhdysvallat, 02903
- Rhode Island Hospital
-
-
South Carolina
-
Columbia, South Carolina, Yhdysvallat, 29203
- Prisma Health Richland Hospital
-
Greenville, South Carolina, Yhdysvallat, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Yhdysvallat, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Yhdysvallat, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, Yhdysvallat, 29605
- BI-LO Charities Children's Cancer Center
-
-
South Dakota
-
Sioux Falls, South Dakota, Yhdysvallat, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
-
Tennessee
-
Knoxville, Tennessee, Yhdysvallat, 37916
- East Tennessee Childrens Hospital
-
Memphis, Tennessee, Yhdysvallat, 38105
- Saint Jude Children's Research Hospital
-
Nashville, Tennessee, Yhdysvallat, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Yhdysvallat, 37203
- The Children's Hospital at TriStar Centennial
-
-
Texas
-
Amarillo, Texas, Yhdysvallat, 79106
- Texas Tech University Health Sciences Center-Amarillo
-
Austin, Texas, Yhdysvallat, 78723
- Dell Children's Medical Center of Central Texas
-
Corpus Christi, Texas, Yhdysvallat, 78411
- Driscoll Children's Hospital
-
Dallas, Texas, Yhdysvallat, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Dallas, Texas, Yhdysvallat, 75230
- Medical City Dallas Hospital
-
El Paso, Texas, Yhdysvallat, 79905
- El Paso Children's Hospital
-
Houston, Texas, Yhdysvallat, 77030
- UT MD Anderson Cancer Center
-
Houston, Texas, Yhdysvallat, 77030
- Houston Methodist Hospital
-
Houston, Texas, Yhdysvallat, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Lubbock, Texas, Yhdysvallat, 79410
- Covenant Children's Hospital
-
Lubbock, Texas, Yhdysvallat, 79415
- UMC Cancer Center / UMC Health System
-
San Antonio, Texas, Yhdysvallat, 78229
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Yhdysvallat, 78207
- Children's Hospital of San Antonio
-
San Antonio, Texas, Yhdysvallat, 78229
- Methodist Children's Hospital of South Texas
-
-
Utah
-
Salt Lake City, Utah, Yhdysvallat, 84113
- Primary Children's Hospital
-
-
Virginia
-
Charlottesville, Virginia, Yhdysvallat, 22908
- University of Virginia Cancer Center
-
Falls Church, Virginia, Yhdysvallat, 22042
- Inova Fairfax Hospital
-
Norfolk, Virginia, Yhdysvallat, 23507
- Children's Hospital of The King's Daughters
-
Richmond, Virginia, Yhdysvallat, 23298
- VCU Massey Comprehensive Cancer Center
-
Roanoke, Virginia, Yhdysvallat, 24014
- Carilion Children's
-
-
Washington
-
Renton, Washington, Yhdysvallat, 98055
- Valley Medical Center
-
Seattle, Washington, Yhdysvallat, 98105
- Seattle Children's Hospital
-
Spokane, Washington, Yhdysvallat, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
-
Tacoma, Washington, Yhdysvallat, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, Yhdysvallat, 98431
- Madigan Army Medical Center
-
-
West Virginia
-
Charleston, West Virginia, Yhdysvallat, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
-
Wisconsin
-
Madison, Wisconsin, Yhdysvallat, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Marshfield, Wisconsin, Yhdysvallat, 54449
- Marshfield Medical Center-Marshfield
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
-
Age >= 2 years
-
Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma
- Children's Oncology Group (COG) Institutions: Use Karnofsky for patients >= 17 and < 18 years of age and Lansky for patients < 17 years of age
-
Adults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. 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
-
Pediatric Patients (age < 18 years): The following must have been obtained within 14 days prior to registration:
-
Measured or calculated (based on institutional standard) creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or
-
Serum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine based on age/sex as follows:
- Age : 2 to < 6 year; Maximum serum creatinine (mg/dL): 0.8 (male; 0.8 (female)
- Age : 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male); 1 (female)
- Age : 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female)
- Age : 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female)
- Age : >= 16 years to < 18 years; Maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female)
-
-
Patients with abnormal liver function will be eligible to enroll if the lab abnormality is thought to be due to the lymphoma or Gilbert's syndrome
-
Age >= 18 years: Ejection fraction of >= 50% by echocardiogram
-
Age < 18 years: Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
-
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
-
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
Exclusion Criteria:
-
Administration of prior anti-cancer therapy except as outlined below:
- A short course (=< 2 weeks) of corticosteroids for the relief of lymphoma-related symptoms
- A single course of COP (cyclophosphamide, vincristine, and prednisone)
- One cycle of chemo-immunotherapy including R-CHOP, DA-EPOCH-R, a pediatric mature B-cell non-Hodgkin lymphoma (B-NHL) induction therapy (such as ANHL1131), or intrathecal chemotherapy that has not started more than 21 days prior to enrollment
-
Active ischemic heart disease or heart failure
-
Active uncontrolled infection
-
Central nervous system (CNS) involvement of lymphoma
-
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this trial
-
Active autoimmune disease that has required systemic treatment (such as disease modifying agents, corticosteroids, or immunosuppressive agents) in the past 2 years. Replacement therapy such as thyroxine, insulin or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment
-
In patients < 18 years of age hepatitis B serologies consistent with past or current infections
-
Patients with severe hepatic impairment (Child-Pugh class C or serum total bilirubin > 5.0 mg/dL) unless thought to be due to lymphoma or Gilbert's syndrome
-
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
-
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 participation
-
Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last dose of rituximab
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Arm A (DA-EPOCH-R)
See Detailed Description |
Given IV
Muut nimet:
Given IV
Muut nimet:
Given PO
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Undergo ECHO
Muut nimet:
Undergo CT or PET/CT
Muut nimet:
Undergo PET/CT
Muut nimet:
Given IV
Muut nimet:
Given SC
Muut nimet:
Undergo bone marrow biopsy and aspiration Undergo bone marrow biopsy and aspiration
Muut nimet:
Given PO
Muut nimet:
Given SC
Muut nimet:
Undergo LP
Muut nimet:
Undergo blood and CSF sample collection
Muut nimet:
Given SC
Muut nimet:
|
|
Kokeellinen: Arm B (DA-EPOCH-R, nivolumab)
Patients receive treatment as in Arm A. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO and LP for CSF collection during screening. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study. |
Given IV
Muut nimet:
Given IV
Muut nimet:
Given PO
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Undergo ECHO
Muut nimet:
Given IV
Muut nimet:
Undergo CT or PET/CT
Muut nimet:
Undergo PET/CT
Muut nimet:
Given IV
Muut nimet:
Given SC
Muut nimet:
Undergo bone marrow biopsy and aspiration Undergo bone marrow biopsy and aspiration
Muut nimet:
Given PO
Muut nimet:
Given SC
Muut nimet:
Undergo LP
Muut nimet:
Undergo blood and CSF sample collection
Muut nimet:
Given SC
Muut nimet:
|
|
Active Comparator: Arm C (R-CHOP)
Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV over 1-15 minutes or up to 60 minutes, and vincristine sulfate IV over 1 or up to 60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study. |
Given IV
Muut nimet:
Given IV
Muut nimet:
Given PO
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Undergo ECHO
Muut nimet:
Undergo CT or PET/CT
Muut nimet:
Undergo PET/CT
Muut nimet:
Undergo bone marrow biopsy and aspiration Undergo bone marrow biopsy and aspiration
Muut nimet:
Given PO
Muut nimet:
Undergo LP
Muut nimet:
Undergo blood and CSF sample collection
Muut nimet:
Given SC
Muut nimet:
|
|
Kokeellinen: Arm D (R-CHOP, nivolumab)
Patients receive treatment as in Arm C. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study. |
Given IV
Muut nimet:
Given IV
Muut nimet:
Given PO
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Undergo ECHO
Muut nimet:
Given IV
Muut nimet:
Undergo CT or PET/CT
Muut nimet:
Undergo PET/CT
Muut nimet:
Undergo bone marrow biopsy and aspiration Undergo bone marrow biopsy and aspiration
Muut nimet:
Given PO
Muut nimet:
Undergo LP
Muut nimet:
Undergo blood and CSF sample collection
Muut nimet:
Given SC
Muut nimet:
|
|
Active Comparator: Arm E (R-CHOP, radiation therapy)
Patients receive treatment as in Arm C. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study. |
Given IV
Muut nimet:
Given IV
Muut nimet:
Given PO
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Undergo ECHO
Muut nimet:
Undergo CT or PET/CT
Muut nimet:
Undergo PET/CT
Muut nimet:
Undergo bone marrow biopsy and aspiration Undergo bone marrow biopsy and aspiration
Muut nimet:
Undergo radiation therapy
Muut nimet:
Given PO
Muut nimet:
Undergo LP
Muut nimet:
Undergo blood and CSF sample collection
Muut nimet:
Given SC
Muut nimet:
|
|
Kokeellinen: Arm F (R-CHOP, nivolumab, radiation therapy)
Patients receive treatment as in Arm D. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study. |
Given IV
Muut nimet:
Given IV
Muut nimet:
Given PO
Muut nimet:
Given IV
Muut nimet:
Undergo ECHO
Muut nimet:
Given IV
Muut nimet:
Undergo CT or PET/CT
Muut nimet:
Undergo PET/CT
Muut nimet:
Undergo bone marrow biopsy and aspiration Undergo bone marrow biopsy and aspiration
Muut nimet:
Undergo radiation therapy
Muut nimet:
Given PO
Muut nimet:
Undergo LP
Muut nimet:
Undergo blood and CSF sample collection
Muut nimet:
Given SC
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Progression-free survival (PFS)
Aikaikkuna: From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 7 years
|
The primary analysis will be a one-sided Log-rank test stratified by choice of backbone and radiation therapy and whether the patient had a cycle of therapy prior to enrolling. |
From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 7 years
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Efficacy-related event-free survival
Aikaikkuna: Up to 7 years
|
Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death. |
Up to 7 years
|
|
Therapy-related event-free survival
Aikaikkuna: Up to 7 years
|
Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death. |
Up to 7 years
|
|
Overall survival
Aikaikkuna: Up to 7 years
|
Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as only death. |
Up to 7 years
|
|
Proportion of positive positron emission tomography (PET) scans
Aikaikkuna: Up to 6 cycle (1 cycle = 21 days)
|
Will be analyzed descriptively with a point estimate and Clopper-Pearson 95% confidence interval in the trial overall and in each treatment arm separately. The prognostic significance of positive PET after 6 cycles of therapy will be evaluated using a Cox proportional hazards regression on PFS with PET result (positive versus [vs.] negative), choice of backbone (rituximab [R]-cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] + radiation therapy [RT] regardless of end-of-therapy imaging vs. R-CHOP without RT unless biopsy positive at end-of-therapy vs. dose-adjusted [DA]-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin [EPOCH]-R without RT unless biopsy positive at end of therapy), and assignment to nivolumab (yes vs. no) as covariates. |
Up to 6 cycle (1 cycle = 21 days)
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Immune profile of patients treated with nivolumab + chemo-immunotherapy
Aikaikkuna: Up to 7 years
|
Analysis will be by paired t-test (for pre- vs. post-treatment measurements) or two-sample equal-variance t-test (for comparisons of nivolumab vs. non-nivolumab or responders [complete response/partial response] vs. non-responders [stable disease/progressive disease]). |
Up to 7 years
|
|
Complete response rate
Aikaikkuna: At the completion of initial planned therapy
|
Will be described using point estimates and Clopper-Pearson 95% confidence intervals for the complete response rate overall and in each treatment arm separately. |
At the completion of initial planned therapy
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Lisa G Roth, Children's Oncology Group
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Peptidit
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Orgaaniset kemikaalit
- Heterosykliset yhdisteet
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Tutkintatekniikat
- Terapeuttiset lääkkeet
- Kliiniset laboratoriotekniikat
- Diagnostiikkatekniikat ja menettelyt
- Diagnoosi
- Puhkaisut
- Kirurgiset toimenpiteet, operatiivinen
- Sytologiset tekniikat
- Sytodiagnoosi
- Hiilivety
- Hiilivedyt, sykliset
- Biologiset tekijät
- Hiilihydraatit
- Fyysiset ilmiöt
- Alkaloidit
- Poltisykliset aromaattiset hiilivedyt
- Hiilivedyt, aromaattiset
- Polisykliset yhdisteet
- Glykosidit
- Glykosidihydrolaasit
- Hydrolaasit
- Entsyymit
- Entsyymit ja koentsyymit
- Polysakkaridilyaasit
- Hiilihappio-lyaasit
- Lyaasit
- Indolit
- Vasta -aineet, monoklonaalinen, humanisoitu
- Vasta -aineet, monoklonaalinen
- Vasta -aineet
- Immunoglobuliinit
- Immunoproteiinit
- Veriproteiinit
- Seerumin globuliinit
- Globuliinit
- Raskaat
- Raskaat
- Steroidit
- Sulatettu rengasyhdisteet
- Diagnostiikkatekniikat, kirurginen
- Kemian tekniikat, analyyttiset
- Spektrianalyysi
- Fosforamidi -sinapit
- Typpisinappiyhdisteet
- Sinappiyhdisteet
- Hiilivety, halogenoitu
- Fosforamidit
- Organofosforiyhdisteet
- Solunväliset signalointipeptidit ja proteiinit
- Raskaat
- Raskaat
- Vinca -alkaloidit
- Secologaniinin tryptamiini -alkaloidit
- Indolialkaloidit
- Indolitsidiinit
- Indolisoija
- Antrasykliinit
- Nafthaceenit
- Aminoglykosidit
- Glykoproteiinit
- Glykoconjugates
- Vasta-aineet, monoklonaalinen, hiiren johdettu
- Daunorubisiini
- Diagnostiikkatekniikat, neurologiset
- Pesäkkeitä stimuloivat tekijät
- Hematopoieettiset solujen kasvutekijät
- Sytokiinit
- Nivolumabi
- Rituksimabi
- Prednisoni
- Prednisoloni
- Syklofosfamidi
- Doksorubisiini
- Vincristine
- Metyyliprednisoloni
- Sädehoito
- Hyaluronoglukosaminidaasi
- Säteily
- Biopsia
- Näytteenkäsittely
- Magneettiresonanssispektroskopia
- Selkäranka
- CT-P10
- Granulosyyttipesäkkeitä stimuloiva tekijä
- Filgrastimi
- deltacortene
- harrastus
- pegfilgrastim
- etoposidifosfaatti
- Pegyloidut granulosyyttikolonia stimuloiva tekijä
Muut tutkimustunnusnumerot
- NCI-2021-01071
- U10CA180886 (Yhdysvaltain NIH-apuraha/sopimus)
- NCI-2021-01071 (Rekisterin tunniste: CTRP (Clinical Trial Reporting Program))
- ANHL1931 (Muu tunniste: CTEP)
- ANHL1931 (Muu tunniste: Children's Oncology Group)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Lääke- ja laitetiedot, tutkimusasiakirjat
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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