Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma
4 other identifiers
interventional
166
5 countries
177
Brief Summary
This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2009
Longer than P75 for phase_3
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2009
CompletedFirst Posted
Study publicly available on registry
December 4, 2009
CompletedStudy Start
First participant enrolled
December 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedApril 28, 2022
December 1, 2021
2.2 years
December 3, 2009
February 8, 2017
April 1, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Second-event-free Survival
Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.
At 4 years from enrollment
Safety Analysis and Monitoring of Toxic Death
The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.
Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).
Secondary Outcomes (6)
Event Free Survival
At 3 years from enrollment
Second-event-free Survival
At 4 years from enrollment
Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
3 years from enrollment
Relapse-free Survival
3 years from enrollment
Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
During and after completion of study treatment.
- +1 more secondary outcomes
Study Arms (3)
Regimen I (consolidation therapy)
EXPERIMENTALPatients receive 2 more courses of ABVE-PC comprising doxorubicin hydrochloride IV over 1-120 minutes and cyclophosphamide IV over 30-60 minutes on days 1 and 2; bleomycin sulfate IV over at least 10 minutes or subcutaneously (SC) and vincristine sulfate IV on days 1 and 8; etoposide IV over 1-2 hours on days 1-3; oral prednisone twice daily on days 1-7; and filgrastim SC or IV daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression.
Regimen II (consolidation therapy)
EXPERIMENTALPatients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, and filgrastim SC or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
Induction: all patient
EXPERIMENTALAll patients receive ABVE-PC induction therapy then they are assigned to Group 2 (RER), Group 3 (SER) or taken off study if they develop progressive disease.
Interventions
Given IV or SC
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV or SC
Given IV
Eligibility Criteria
You may qualify if:
- Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the following criteria:
- Classical disease
- Nodular lymphocyte-predominant disease
- Stage III or IV disease with B symptoms, as defined by ≥ 1 of the following:
- Unexplained weight loss \> 10% within the past 6 months
- Unexplained recurrent fever \> 38°C within the past month
- Recurrent drenching night sweats within the past month
- Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:
- mg/dL (1 to 5 months)
- mg/dL (6 to 11 months)
- mg/dL (12 to 23 months)
- mg/dL (2 to 5 years)
- mg/dL (6 to 9 years)
- mg/dL (10 to 12 years)
- mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (177)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of South Alabama
Mobile, Alabama, 36604, United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Southern California Permanente Medical Group
Downey, California, 90242, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Miller Children's Hospital
Long Beach, California, 90806, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital Central California
Madera, California, 93636-8762, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Childrens Hospital of Orange County
Orange, California, 92868-3874, United States
University of California at Davis Cancer Center
Sacramento, California, 95817, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93102, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Yale University
New Haven, Connecticut, 06520, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, 20057, United States
Lee Memorial Health System
Fort Myers, Florida, 33901, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, 32207, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Florida Hospital
Orlando, Florida, 32803, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, 32806, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, 33607, United States
Saint Mary's Hospital
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453, United States
Advocate Lutheran General Hospital.
Park Ridge, Illinois, 60068, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61602, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260, United States
Blank Children's Hospital
Des Moines, Iowa, 50309, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Children's Hospital-Main Campus
New Orleans, Louisiana, 70118, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Michigan State University Clinical Center
East Lansing, Michigan, 48824-7016, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, 49008, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Columbia Regional
Columbia, Missouri, 65201, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
The Childrens Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
University of New Mexico
Albuquerque, New Mexico, 87106, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
Columbia University Medical Center
New York, New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Weill Medical College of Cornell University
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490, United States
New York Medical College
Valhalla, New York, 10595, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, 28801, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, 58122, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Oncology Group
Philadelphia, Pennsylvania, 19104, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605, United States
Greenville Cancer Treatment Center
Greenville, South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Covenant Children's Hospital
Lubbock, Texas, 79410, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
University of Vermont
Burlington, Vermont, 05401, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Childrens Hospital-King's Daughters
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
West Virginia University Charleston
Charleston, West Virginia, 25304, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, 5006, Australia
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6008, Australia
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, G1V 4G2, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Schneider Children's Medical Center of Israel
Petah Tikua, 49202, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
San Jorge Children's Hospital
San Juan, 00912, Puerto Rico
Related Publications (2)
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.
PMID: 39969278DERIVEDCastellino 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.
PMID: 37505794DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Kara Kelly, MD
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2009
First Posted
December 4, 2009
Study Start
December 7, 2009
Primary Completion
March 1, 2012
Study Completion
March 31, 2022
Last Updated
April 28, 2022
Results First Posted
May 30, 2017
Record last verified: 2021-12