Brentuximab Vedotin és kombinált kemoterápia IIB, IIIB, IVA vagy IVB stádiumú Hodgkin limfómában szenvedő gyermekek és fiatal felnőttek kezelésében
A Brentuximab Vedotin (SGN-35) véletlenszerű 3. fázisú vizsgálata újonnan diagnosztizált, nagy kockázatú klasszikus Hodgkin limfómára (cHL) gyermekeknél és fiatal felnőtteknél
This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Chemotherapy drugs, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, 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. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating children with high-risk Hodgkin lymphoma.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
- Egyéb: Laboratory Biomarker Analysis
- Egyéb: Quality-of-Life Assessment
- Drog: Cyclophosphamide
- Drog: Doxorubicin Hydrochloride
- Drog: Prednisone
- Drog: Vincristine Sulfate
- Egyéb: Questionnaire Administration
- Drog: Brentuximab Vedotin
- Drog: Etoposide
- Egyéb: Pharmacological Study
- Biológiai: Bleomycin Sulfate
- Drog: Methylprednisolone
Részletes leírás
PRIMARY OBJECTIVE:
I. To assess the event free survival (EFS) of a novel regimen incorporating brentuximab vedotin (Bv; Adcetris) in the chemotherapy backbone of doxorubicin hydrochloride (doxorubicin) (Adriamycin), vincristine sulfate (vincristine), etoposide, prednisone and cyclophosphamide (Bv-AVEPC) in newly diagnosed high-risk classical Hodgkin lymphoma (cHL) compared to those treated with Adriamycin, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC).
SECONDARY OBJECTIVES:
I. To determine whether children/young adults with high-risk cHL treated with Bv-AVEPC have a higher rate of early response (determined by fludeoxyglucose F 18 [FDG]-positron emission tomography [PET]) and a reduction in protocol directed radiation therapy (RT) compared to those treated with ABVE-PC.
II. To compare the rate of neuropathy (>= grade 3) among patients treated on the Bv-AVEPC (experimental arm) to patients treated on the ABVE-PC (standard arm).
EXPLORATORY OBJECTIVES:
I. To validate and compare the Childhood Hodgkin International Prognostic Score (CHIPS) to conventional Ann Arbor stage (stages II B with bulk, III B, IV A or B) in predicting outcome in high-risk childhood cHL.
II. To determine the incidence of preferentially expressed antigen in melanoma (PRAME) and testis-specific antigens in Epstein-Barr virus (EBV)- cHL tumors and the incidence of EBV antigens (Epstein-Barr nuclear antigen 1 [EBNA1], Epstein-Barr virus latent membrane protein 1 [LMP1], large multifunctional peptidase 2 [LMP2]) in EBV+ cHL tumors, with the goal of developing strategies to integrate cellular therapy into treatment for newly diagnosed high-risk cHL. (Biology) III. To incorporate qualitative visual FDG-PET into response-directed treatment algorithms and explore quantitative FDG-PET and computed tomography (CT) definitions of tumor burden and response for incorporation into next generation pediatric cHL risk-stratification schemes, exploring the extension of these algorithms to young adults. (Imaging) IV. To evaluate the reduction in normal tissue irradiation associated with the current treatment approach compared to the volume of historic involved field radiation therapy (IFRT) fields. (Radiation Therapy) V. To evaluate EFS and patterns of relapse following protocol-specified RT utilization and treatment volumes. (Radiation Therapy) VI. To characterize the extent of chemotherapy induced peripheral neuropathy (CIPN), as reported by patients and parent proxies, through serial administration of the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-NTX). (Patient Reported Outcomes [PRO] of Peripheral Neuropathy and Health-Related Quality of Life) VII. To describe the Health-Related Quality of Life (HRQL) consequences of peripheral neuropathy over time by correlating total neuropathy scale scores with the individual items with the Child Health Ratings Inventories (CHRIs)-Global scale (e.g., physical health, pain, emotional functioning). (PRO of Peripheral Neuropathy and Health-Related Quality of Life) VIII. To perform a cross validation of the FACT-GOG-NTX with the Total Neuropathy Score-Pediatric Vincristine (TNS-PV) to determine the performance of both measures with the use of brentuximab vedotin in a limited institutional approach in children and adolescents with cHL. (PRO of Peripheral Neuropathy and Health-Related Quality of Life) IX. To assess the resource use and cost implications of Bv in combination with chemotherapy and radiotherapy (RT) for newly diagnosed high-risk cHL in children and young adults. (Economic) X. To estimate the risk of relapse among rapidly responding lesions (RRL) subjects that have at least one lesion that is Deauville 3 at PET 2. (Follow-up of Deauville score 3 lesions on FDG-PET imaging [confirmed by central imaging review]) XI. To characterize the pharmacokinetics of brentuximab vedotin in children < 13 years of age.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (ABVE-PC): Patients receive doxorubicin hydrochloride intravenously (IV) over on days 1-2, bleomycin sulfate IV or subcutaneously (SC) on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally (PO) twice daily (BID) or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2.
ARM II (Bv-AVEPC): Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8.
In both arms, treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Granulocyte simulating factor (GCSF) or equivalent is given on both arms.
After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 3. fázis
Kapcsolatok és helyek
Tanulmányi helyek
-
-
Alabama
-
Birmingham, Alabama, Egyesült Államok, 35233
- Children's Hospital of Alabama
-
Mobile, Alabama, Egyesült Államok, 36604
- USA Health Strada Patient Care Center
-
-
Alaska
-
Anchorage, Alaska, Egyesült Államok, 99508
- Providence Alaska Medical Center
-
-
Arizona
-
Mesa, Arizona, Egyesült Államok, 85202
- Banner Children's at Desert
-
Phoenix, Arizona, Egyesült Államok, 85016
- Phoenix Childrens Hospital
-
Tucson, Arizona, Egyesült Államok, 85719
- Banner University Medical Center - Tucson
-
-
Arkansas
-
Little Rock, Arkansas, Egyesült Államok, 72202-3591
- Arkansas Children's Hospital
-
-
California
-
Downey, California, Egyesült Államok, 90242
- Kaiser Permanente Downey Medical Center
-
Duarte, California, Egyesült Államok, 91010
- City of Hope Comprehensive Cancer Center
-
Loma Linda, California, Egyesült Államok, 92354
- Loma Linda University Medical Center
-
Long Beach, California, Egyesült Államok, 90806
- Miller Children's and Women's Hospital Long Beach
-
Los Angeles, California, Egyesült Államok, 90048
- Cedars-Sinai Medical Center
-
Los Angeles, California, Egyesült Államok, 90027
- Children's Hospital Los Angeles
-
Madera, California, Egyesült Államok, 93636
- Valley Children's Hospital
-
Oakland, California, Egyesült Államok, 94611
- Kaiser Permanente-Oakland
-
Orange, California, Egyesült Államok, 92868
- Children's Hospital of Orange County
-
Sacramento, California, Egyesült Államok, 95816
- Sutter Medical Center Sacramento
-
Sacramento, California, Egyesült Államok, 95817
- University of California Davis Comprehensive Cancer Center
-
San Diego, California, Egyesült Államok, 92123
- Rady Children's Hospital - San Diego
-
San Diego, California, Egyesült Államok, 92134
- Naval Medical Center -San Diego
-
Santa Barbara, California, Egyesült Államok, 93102
- Santa Barbara Cottage Hospital
-
Torrance, California, Egyesült Államok, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
-
-
Colorado
-
Aurora, Colorado, Egyesült Államok, 80045
- Children's Hospital Colorado
-
Denver, Colorado, Egyesült Államok, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
-
-
Connecticut
-
Hartford, Connecticut, Egyesült Államok, 06106
- Connecticut Children's Medical Center
-
New Haven, Connecticut, Egyesült Államok, 06520
- Yale University
-
-
Delaware
-
Wilmington, Delaware, Egyesült Államok, 19803
- Alfred I duPont Hospital for Children
-
-
District of Columbia
-
Washington D.C., District of Columbia, Egyesült Államok, 20010
- Children's National Medical Center
-
Washington D.C., District of Columbia, Egyesült Államok, 20007
- MedStar Georgetown University Hospital
-
-
Florida
-
Fort Lauderdale, Florida, Egyesült Államok, 33316
- Broward Health Medical Center
-
Fort Myers, Florida, Egyesült Államok, 33908
- Golisano Children's Hospital of Southwest Florida
-
Gainesville, Florida, Egyesült Államok, 32610
- UF Health Cancer Institute - Gainesville
-
Hollywood, Florida, Egyesült Államok, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
-
Jacksonville, Florida, Egyesült Államok, 32207
- Nemours Children's Clinic-Jacksonville
-
Miami, Florida, Egyesült Államok, 33155
- Nicklaus Children's Hospital
-
Miami, Florida, Egyesült Államok, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Miami, Florida, Egyesült Államok, 33176
- Miami Cancer Institute
-
Orlando, Florida, Egyesült Államok, 32827
- Nemours Children's Hospital
-
Orlando, Florida, Egyesült Államok, 32803
- AdventHealth Orlando
-
Orlando, Florida, Egyesült Államok, 32806
- Arnold Palmer Hospital for Children
-
Pensacola, Florida, Egyesült Államok, 32504
- Nemours Children's Clinic - Pensacola
-
St. Petersburg, Florida, Egyesült Államok, 33701
- Johns Hopkins All Children's Hospital
-
Tampa, Florida, Egyesült Államok, 33606
- Tampa General Hospital
-
Tampa, Florida, Egyesült Államok, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
-
West Palm Beach, Florida, Egyesült Államok, 33407
- Saint Mary's Medical Center
-
-
Georgia
-
Atlanta, Georgia, Egyesült Államok, 30329
- Children's Healthcare of Atlanta - Arthur M Blank Hospital
-
Augusta, Georgia, Egyesült Államok, 30912
- Augusta University Medical Center
-
Savannah, Georgia, Egyesült Államok, 31404
- Memorial Health University Medical Center
-
-
Hawaii
-
Honolulu, Hawaii, Egyesült Államok, 96826
- Kapiolani Medical Center for Women and Children
-
-
Idaho
-
Boise, Idaho, Egyesült Államok, 83712
- Saint Luke's Cancer Institute - Boise
-
-
Illinois
-
Chicago, Illinois, Egyesült Államok, 60637
- University of Chicago Comprehensive Cancer Center
-
Chicago, Illinois, Egyesült Államok, 60612
- University of Illinois
-
Chicago, Illinois, Egyesült Államok, 60611
- Lurie Children's Hospital-Chicago
-
Maywood, Illinois, Egyesült Államok, 60153
- Loyola University Medical Center
-
Oak Lawn, Illinois, Egyesült Államok, 60453
- Advocate Children's Hospital-Oak Lawn
-
Park Ridge, Illinois, Egyesült Államok, 60068
- Advocate Children's Hospital-Park Ridge
-
Peoria, Illinois, Egyesült Államok, 61637
- OSF Children's Hospital of Illinois
-
Springfield, Illinois, Egyesült Államok, 62702
- Southern Illinois University School of Medicine
-
-
Indiana
-
Indianapolis, Indiana, Egyesült Államok, 46202
- Riley Hospital for Children
-
Indianapolis, Indiana, Egyesült Államok, 46260
- Ascension Saint Vincent Indianapolis Hospital
-
-
Iowa
-
Des Moines, Iowa, Egyesült Államok, 50309
- Blank Children's Hospital
-
Iowa City, Iowa, Egyesült Államok, 52242
- University of Iowa/Holden Comprehensive Cancer Center
-
-
Kentucky
-
Lexington, Kentucky, Egyesült Államok, 40536
- University of Kentucky/Markey Cancer Center
-
Louisville, Kentucky, Egyesült Államok, 40202
- Norton Children's Hospital
-
-
Louisiana
-
New Orleans, Louisiana, Egyesült Államok, 70121
- Ochsner Medical Center Jefferson
-
New Orleans, Louisiana, Egyesült Államok, 70118
- Children's Hospital New Orleans
-
-
Maine
-
Bangor, Maine, Egyesült Államok, 04401
- Eastern Maine Medical Center
-
-
Maryland
-
Baltimore, Maryland, Egyesült Államok, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Baltimore, Maryland, Egyesült Államok, 21215
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, Egyesült Államok, 21201
- University of Maryland/Greenebaum Cancer Center
-
Bethesda, Maryland, Egyesült Államok, 20889-5600
- Walter Reed National Military Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Egyesült Államok, 02111
- Tufts Children's Hospital
-
Springfield, Massachusetts, Egyesült Államok, 01199
- Baystate Medical Center
-
Worcester, Massachusetts, Egyesült Államok, 01655
- UMass Memorial Medical Center - University Campus
-
-
Michigan
-
Ann Arbor, Michigan, Egyesült Államok, 48109
- C S Mott Children's Hospital
-
Detroit, Michigan, Egyesült Államok, 48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, Egyesült Államok, 48236
- Henry Ford Health Saint John Hospital
-
East Lansing, Michigan, Egyesült Államok, 48823
- Michigan State University
-
Flint, Michigan, Egyesült Államok, 48503
- Hurley Medical Center
-
Grand Rapids, Michigan, Egyesült Államok, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
-
Kalamazoo, Michigan, Egyesült Államok, 49007
- Bronson Methodist Hospital
-
Royal Oak, Michigan, Egyesült Államok, 48073
- Corewell Health Children's
-
-
Minnesota
-
Minneapolis, Minnesota, Egyesült Államok, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
-
Minneapolis, Minnesota, Egyesült Államok, 55455
- University of Minnesota/Masonic Cancer Center
-
Rochester, Minnesota, Egyesült Államok, 55905
- Mayo Clinic in Rochester
-
-
Mississippi
-
Jackson, Mississippi, Egyesült Államok, 39216
- University of Mississippi Medical Center
-
-
Missouri
-
Columbia, Missouri, Egyesült Államok, 65212
- University of Missouri Children's Hospital
-
Kansas City, Missouri, Egyesült Államok, 64108
- Children's Mercy Hospitals and Clinics
-
St Louis, Missouri, Egyesült Államok, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Egyesült Államok, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Egyesült Államok, 63104
- Cardinal Glennon Children's Medical Center
-
-
Nebraska
-
Omaha, Nebraska, Egyesült Államok, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, Egyesült Államok, 68114
- Children's Hospital and Medical Center of Omaha
-
-
Nevada
-
Las Vegas, Nevada, Egyesült Államok, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Egyesült Államok, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, Egyesült Államok, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Egyesült Államok, 89102
- University Medical Center of Southern Nevada
-
-
New Hampshire
-
Lebanon, New Hampshire, Egyesült Államok, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Hackensack, New Jersey, Egyesült Államok, 07601
- Hackensack University Medical Center
-
Morristown, New Jersey, Egyesült Államok, 07960
- Morristown Medical Center
-
New Brunswick, New Jersey, Egyesült Államok, 08901
- Saint Peter's University Hospital
-
New Brunswick, New Jersey, Egyesült Államok, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
-
Newark, New Jersey, Egyesült Államok, 07112
- Newark Beth Israel Medical Center
-
Paterson, New Jersey, Egyesült Államok, 07503
- Saint Joseph's Regional Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Egyesült Államok, 87106
- University of New Mexico Cancer Center
-
-
New York
-
Albany, New York, Egyesült Államok, 12208
- Albany Medical Center
-
Buffalo, New York, Egyesült Államok, 14263
- Roswell Park Cancer Institute
-
Mineola, New York, Egyesült Államok, 11501
- NYU Langone Hospital - Long Island
-
New Hyde Park, New York, Egyesült Államok, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
-
New York, New York, Egyesült Államok, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, Egyesült Államok, 10029
- Mount Sinai Hospital
-
New York, New York, Egyesült Államok, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, Egyesült Államok, 10065
- NYP/Weill Cornell Medical Center
-
New York, New York, Egyesült Államok, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, Egyesült Államok, 14642
- University of Rochester
-
Stony Brook, New York, Egyesült Államok, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Egyesült Államok, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Egyesült Államok, 10467
- Montefiore Medical Center - Moses Campus
-
-
North Carolina
-
Asheville, North Carolina, Egyesült Államok, 28801
- Mission Hospital
-
Chapel Hill, North Carolina, Egyesült Államok, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, Egyesült Államok, 28203
- Carolinas Medical Center/Levine Cancer Institute
-
Charlotte, North Carolina, Egyesült Államok, 28204
- Novant Health Presbyterian Medical Center
-
Durham, North Carolina, Egyesült Államok, 27710
- Duke University Medical Center
-
Greenville, North Carolina, Egyesült Államok, 27834
- East Carolina University
-
Winston-Salem, North Carolina, Egyesült Államok, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Fargo, North Dakota, Egyesült Államok, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, Egyesült Államok, 44308
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, Egyesült Államok, 45229
- Cincinnati Children's Hospital Medical Center
-
Cleveland, Ohio, Egyesült Államok, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Egyesült Államok, 44106
- Rainbow Babies and Childrens Hospital
-
Columbus, Ohio, Egyesült Államok, 43205
- Nationwide Children's Hospital
-
Dayton, Ohio, Egyesült Államok, 45404
- Dayton Children's Hospital
-
Toledo, Ohio, Egyesült Államok, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Egyesült Államok, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Portland, Oregon, Egyesült Államok, 97239
- Oregon Health and Science University
-
Portland, Oregon, Egyesült Államok, 97227
- Legacy Emanuel Children's Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Egyesült Államok, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Egyesült Államok, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Danville, Pennsylvania, Egyesült Államok, 17822
- Geisinger Medical Center
-
Hershey, Pennsylvania, Egyesült Államok, 17033
- Penn State Children's Hospital
-
Philadelphia, Pennsylvania, Egyesült Államok, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Egyesült Államok, 19134
- Saint Christopher's Hospital for Children
-
Pittsburgh, Pennsylvania, Egyesült Államok, 15224
- Children's Hospital of Pittsburgh of UPMC
-
-
Rhode Island
-
Providence, Rhode Island, Egyesült Államok, 02903
- Rhode Island Hospital
-
-
South Carolina
-
Charleston, South Carolina, Egyesült Államok, 29425
- Medical University of South Carolina
-
Columbia, South Carolina, Egyesült Államok, 29203
- Prisma Health Richland Hospital
-
Greenville, South Carolina, Egyesült Államok, 29605
- BI-LO Charities Children's Cancer Center
-
-
South Dakota
-
Sioux Falls, South Dakota, Egyesült Államok, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
-
Tennessee
-
Chattanooga, Tennessee, Egyesült Államok, 37403
- T C Thompson Children's Hospital
-
Knoxville, Tennessee, Egyesült Államok, 37916
- East Tennessee Childrens Hospital
-
Nashville, Tennessee, Egyesült Államok, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Egyesült Államok, 37203
- The Children's Hospital at TriStar Centennial
-
-
Texas
-
Austin, Texas, Egyesült Államok, 78723
- Dell Children's Medical Center of Central Texas
-
Corpus Christi, Texas, Egyesült Államok, 78411
- Driscoll Children's Hospital
-
Dallas, Texas, Egyesült Államok, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Dallas, Texas, Egyesült Államok, 75230
- Medical City Dallas Hospital
-
El Paso, Texas, Egyesült Államok, 79905
- El Paso Children's Hospital
-
Fort Worth, Texas, Egyesült Államok, 76104
- Cook Children's Medical Center
-
Houston, Texas, Egyesült Államok, 77030
- UT MD Anderson Cancer Center
-
Houston, Texas, Egyesült Államok, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Lubbock, Texas, Egyesült Államok, 79410
- Covenant Children's Hospital
-
Lubbock, Texas, Egyesült Államok, 79415
- UMC Cancer Center / UMC Health System
-
San Antonio, Texas, Egyesült Államok, 78229
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Egyesült Államok, 78207
- Children's Hospital of San Antonio
-
San Antonio, Texas, Egyesült Államok, 78229
- Methodist Children's Hospital of South Texas
-
Temple, Texas, Egyesült Államok, 76508
- Scott and White Memorial Hospital
-
-
Utah
-
Salt Lake City, Utah, Egyesült Államok, 84113
- Primary Children's Hospital
-
-
Vermont
-
Burlington, Vermont, Egyesült Államok, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Charlottesville, Virginia, Egyesült Államok, 22908
- University of Virginia Cancer Center
-
Falls Church, Virginia, Egyesült Államok, 22042
- Inova Fairfax Hospital
-
Norfolk, Virginia, Egyesült Államok, 23507
- Children's Hospital of The King's Daughters
-
Richmond, Virginia, Egyesült Államok, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Seattle, Washington, Egyesült Államok, 98105
- Seattle Children's Hospital
-
Spokane, Washington, Egyesült Államok, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
-
Tacoma, Washington, Egyesült Államok, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, Egyesült Államok, 98431
- Madigan Army Medical Center
-
-
West Virginia
-
Charleston, West Virginia, Egyesült Államok, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Morgantown, West Virginia, Egyesült Államok, 26506
- West Virginia University Healthcare
-
-
Wisconsin
-
Green Bay, Wisconsin, Egyesült Államok, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Madison, Wisconsin, Egyesült Államok, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Marshfield, Wisconsin, Egyesült Államok, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Egyesült Államok, 53226
- Children's Hospital of Wisconsin
-
-
-
-
-
Québec, Kanada, G1V 4G2
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
-
-
Alberta
-
Calgary, Alberta, Kanada, T3B 6A8
- Alberta Children's Hospital
-
Edmonton, Alberta, Kanada, T6G 2B7
- University of Alberta Hospital
-
-
British Columbia
-
Vancouver, British Columbia, Kanada, V6H 3V4
- British Columbia Children's Hospital
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R3E 0V9
- CancerCare Manitoba
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3K 6R8
- IWK Health Centre
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
-
Kingston, Ontario, Kanada, K7L 2V7
- Kingston Health Sciences Centre
-
London, Ontario, Kanada, N6A 5W9
- Children's Hospital
-
Ottawa, Ontario, Kanada, K1H 8L1
- Children's Hospital of Eastern Ontario
-
Toronto, Ontario, Kanada, M5G 1X8
- Hospital for Sick Children
-
-
Quebec
-
Montreal, Quebec, Kanada, H3H 1P3
- The Montreal Children's Hospital of the MUHC
-
Montreal, Quebec, Kanada, H3T 1C5
- Centre Hospitalier Universitaire Sainte-Justine
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre
-
-
-
-
-
Caguas, Puerto Rico, 00726
- HIMA San Pablo Oncologic Hospital
-
San Juan, Puerto Rico, 00926
- University Pediatric Hospital
-
San Juan, Puerto Rico, 00912
- San Jorge Children's Hospital
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
-
Patients with newly diagnosed, pathologically confirmed cHL meeting one of the following Ann Arbor stages are eligible:
-
Stage IIB with bulk
-
Stage IIIB
-
Stage IVA
-
Stage IVB
- If study eligibility by staging is uncertain, consultation with Imaging and Radiation Oncology Core (IROC) Rhode Island (RI) may be obtained prior to study enrollment
-
-
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (performed within 14 days prior to enrollment):
- 2 to < 6 years: male 0.8 mg/dL, female 0.8 mg/dL
- 6 to < 10 years: male 1 mg/dL, female 1 mg/dL
- 10 to < 13 years: male 1.2 mg/dL, female 1.2 mg/dL
- 13 to < 16 years: male 1.5 mg/dL, female 1.4 mg/dL
- >= 16 years: male 1.7 mg/dL, female 1.4 mg/dL
-
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 14 days prior to enrollment)
-
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine transaminase [ALT]) < 2.5 x upper limit of normal (ULN) for age (performed within 14 days prior to enrollment)
-
Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
-
Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from Hodgkin lymphoma (HL)
-
For children who are unable to cooperate for PFTs, the criteria are: no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry reading of > 92% on room air
-
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:
- Patients with nodular lymphocyte-predominant HL
- Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible
- Patients who are pregnant; (since fetal toxicities and teratogenic effects have been noted for several of the study drugs, a negative pregnancy test is required for female patients of childbearing potential)
- Lactating females who plan to breastfeed
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 30 days after the last dose of chemotherapy
- Patients known to be positive for human immunodeficiency virus (HIV) are not eligible
- Patients who have received any previous chemotherapy or radiation therapy are not eligible
- Patients who received systemic corticosteroids within 28 days of enrollment on this protocol, except as specified, are not eligible
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: Arm I (ABVE-PC)
Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity. |
Correlative studies Ancillary studies
Más nevek:
Given IV
Más nevek:
Given IV
Más nevek:
Given PO
Más nevek:
Given IV
Más nevek:
Ancillary studies Given IV
Más nevek:
Correlative studies Given IV or SC
Más nevek:
Given IV
Más nevek:
|
|
Kísérleti: ARM II (Bv-AVEPC)
Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity. |
Correlative studies Ancillary studies
Más nevek:
Given IV
Más nevek:
Given IV
Más nevek:
Given PO
Más nevek:
Given IV
Más nevek:
Ancillary studies Given IV
Más nevek:
Given IV
Más nevek:
Correlative studies Given IV
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
Időkeret: Up to 48 months after the last enrollment
|
Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. |
Up to 48 months after the last enrollment
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
Időkeret: After 42 days of chemotherapy
|
The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. |
After 42 days of chemotherapy
|
|
Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
Időkeret: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.
|
The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The "Modified Balis scale of Pediatric Neuropathy" allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score >/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05. |
From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Childhood International Prognostic Score (CHIPS) Score
Időkeret: Baseline
|
CHIPS will be computed for all patients and summarized by descriptive statistics. Will examine the association between CHIPS and early response by cross-tabulations and Chi-square tests within each arm separately, as well as logistic regression model where early response is the outcome variable and CHIPS the predictor variable combining the 2 arms with adjustment for randomized chemotherapy. |
Baseline
|
|
Dose of Radiation Received by Normal Tissues Following Chemotherapy on Either Study Arm
Időkeret: Up to 48 months
|
Descriptive statistics will be used to summarize RT doses received by normal tissues on this study. Two-sample t-test will be used to compare the doses received on this study to those on prior studies. |
Up to 48 months
|
|
Efficacy of Involved Site Radiotherapy (ISRT) by Analyzing the Event-free Survival of Patients Treated With Response-adapted ISRT and by Evaluating Patterns of Relapse Following ISRT
Időkeret: Up to 3 years
|
EFS for patients on each arm as well as those receiving ISRT or those with slow early response (SER) on each arm will be estimated. One-sample log rank test will be used to compare the observed EFS to the assumed baseline of 82% at 3 years to see if the observed EFS is significantly lower than the projection in these subsets. |
Up to 3 years
|
|
Risk of Relapse Among RRL Subjects That Have at Least One Lesion That is Deauville 3 at PET 2
Időkeret: Up to 48 months after the last enrollment
|
The risk of relapse for cases that are RRL, but have Deauville 3 lesions, will be compared to those that are classified as complete metabolic response at PET2 with solely Deauville 1 or 2 lesions with K-sample test. |
Up to 48 months after the last enrollment
|
|
Pharmacokinetic (PK) Analyses
Időkeret: Pre-dose and end of infusion on day 1, days 2, 3, 8, and 15 of cycle 4 and pre-dose on day 1 and day 22 of cycle 5 (each cycle = 21 days)
|
PK concentration time profile will be evaluated. |
Pre-dose and end of infusion on day 1, days 2, 3, 8, and 15 of cycle 4 and pre-dose on day 1 and day 22 of cycle 5 (each cycle = 21 days)
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Sharon M Castellino, Children's Oncology Group
Publikációk és hasznos linkek
Általános kiadványok
- Castellino SM, Pei Q, Parsons SK, Hodgson D, McCarten K, Horton T, Cho S, Wu Y, Punnett A, Dave H, Henderson TO, Hoppe BS, Charpentier AM, Keller FG, Kelly KM. Brentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkin's Lymphoma. N Engl J Med. 2022 Nov 3;387(18):1649-1660. doi: 10.1056/NEJMoa2206660.
- Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28.
- Tie X, Shin M, Lee C, Perlman SB, Huemann Z, Weisman AJ, Castellino SM, Kelly KM, McCarten KM, Alazraki AL, Hu J, Cho SY, Bradshaw TJ. Automatic Quantification of Serial PET/CT Images for Pediatric Hodgkin Lymphoma Using a Longitudinally Aware Segmentation Network. Radiol Artif Intell. 2025 May;7(3):e240229. doi: 10.1148/ryai.240229.
- Pabari R, McCarten K, Flerlage J, Lai H, Mauz-Korholz C, Dieckmann K, Palese M, Kaste S, Castellino SM, Kelly KM, Stoevesandt D, Kurch L. Hodgkin lymphoma involving the extra-axial CNS: an AHOD1331, PHL-C1, and PHL-C2 report from the COG and EuroNet-PHL. Blood Adv. 2024 Sep 24;8(18):4856-4865. doi: 10.1182/bloodadvances.2023012346.
- Williams AM, Rodday AM, Pei Q, Henderson TO, Keller FG, Punnett A, Kelly KM, Castellino SM, Parsons SK. Longitudinal Health-Related Quality of Life Among Patients With High-Risk Pediatric Hodgkin Lymphoma Treated on the Children's Oncology Group AHOD 1331 Study. J Clin Oncol. 2024 Oct;42(28):3330-3338. doi: 10.1200/JCO.24.00038. Epub 2024 Jul 26.
- Parsons SK, Rodday AM, Pei Q, Keller FG, Wu Y, Henderson TO, Cella D, Kelly KM, Castellino SM. Performance of the FACT-GOG-Ntx to assess chemotherapy-induced peripheral neuropathy (CIPN) in pediatric high risk Hodgkin lymphoma: report from the Children's Oncology Group AHOD 1331 study. J Patient Rep Outcomes. 2023 Nov 10;7(1):113. doi: 10.1186/s41687-023-00653-0.
- Hoppe BS, McCarten KM, Pei Q, Kessel S, Alazraki A, Mhlanga JC, Lai HA, Eutsler E, Hodgson DC, Roberts KB, Charpentier AM, Keller FG, Voss SD, Wu Y, Cho SY, Kelly KM, Castellino SM. Importance of Central Imaging Review in a Pediatric Hodgkin Lymphoma Trial Using Positron Emission Tomography Response Adapted Radiation Therapy. Int J Radiat Oncol Biol Phys. 2023 Aug 1;116(5):1025-1030. doi: 10.1016/j.ijrobp.2023.02.020. Epub 2023 Mar 2.
- Williams AM, Rodday AM, Renfro LA, Wu Y, Henderson TO, Keller FG, Punnett A, Hodgson D, Kelly KM, Castellino SM, Parsons SK. Group-based trajectories of health-related quality of life among pediatric patients with high-risk Hodgkin lymphoma. J Natl Cancer Inst. 2025 Oct 1;117(10):2112-2119. doi: 10.1093/jnci/djaf197.
- Toner K, Renfro LA, Dave H, Pezzella G, Pei Q, Giulino-Roth L, Horton T, Keller FG, Kelly KM, Castellino SM, Bollard CM. Tumor-specific immune responses and biomarkers in pediatric patients with high-risk Hodgkin lymphoma. Blood Adv. 2026 Jan 13;10(1):183-191. doi: 10.1182/bloodadvances.2025016797.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becsült)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Peptidek
- Aminosavak, peptidek és fehérjék
- Oligopeptidek
- Fehérjék
- Szerves vegyi anyagok
- Heterociklusos vegyületek
- Heterociklusos vegyületek, 2 gyűrű
- Heterociklusos vegyületek, olvasztott gyűrű
- Szénhidrogének
- Szénhidrogének, ciklikus
- Szénhidrátok
- Alkaloidok
- Podofillotoxin
- Tetrahidronaftalének
- Naftalének
- Policiklusos aromás szénhidrogének
- Szénhidrogének, aromás
- Policiklusos vegyületek
- Glükozidok
- Glikozidok
- Indolok
- Antitestek, monoklonális, humanizált
- Antitestek, monoklonális
- Antitestek
- Immunoglobulinok
- Immunoproteinek
- Vérfehérjék
- Szérumglobulinok
- Globulinok
- Terhesség
- Terhesség
- Szteroidok
- Olvasztott gyűrűs vegyületek
- Foszforamid mustárok
- Nitrogén mustárvegyületek
- Mustárvegyületek
- Szénhidrogén, halogénezett
- Foszforamidok
- Szerves foszfor vegyületek
- Remoklóriumok
- Szurkolók
- Vinca alkaloidok
- Secologlanin triptamin alkaloidok
- Indol -alkaloidok
- Indolizidinek
- Indolizinek
- Antraciklinok
- Nafthacének
- Aminoglikozidok
- Glikokonjugátumok
- Daunorubicin
- Glikopeptidek
- Prednizolon
- Brentuximab Vedotin
- Prednizon
- Ciklofoszfamid
- Etoposide
- Doxorubicin
- Vincristine
- Metilprednizolon
- Bleomicin
- deltacortén
- prednilidén
- vándorló
- Medrol veriderm
Egyéb vizsgálati azonosító számok
- NCI-2014-01223
- U10CA180886 (Az Egyesült Államok NIH támogatása/szerződése)
- NCI-2014-01223 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- s15-00950
- AHOD1331 (Egyéb azonosító: CTEP)
- AHOD1331 (Egyéb azonosító: Children's Oncology Group)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .