Clinical trial · Interventional
Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease
NCT00025259CI-TRIAL-00026953completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma | Childhood Lymphocyte-Depleted Classic Hodgkin Lymphoma | ALIAS | 0.90 |
| Childhood Mixed Cellularity Classical Hodgkin Lymphoma | Childhood Mixed Cellularity Classic Hodgkin Lymphoma | ALIAS | 0.90 |
| Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma | Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma | ALIAS | 0.90 |
| Childhood Nodular Sclerosis Classical Hodgkin Lymphoma | Childhood Nodular Sclerosis Classic Hodgkin Lymphoma | ALIAS | 0.90 |
| Stage I Childhood Hodgkin Lymphoma | Childhood Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage II Childhood Hodgkin Lymphoma | Childhood Hodgkin Lymphoma |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin Sulfate | Biological | Bleomycin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Arm I (Patients off-therapy before callback-Induction only)
- description
- Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.
- interventionNames
- Biological: Bleomycin Sulfate
- Drug: Cyclophosphamide
- Drug: Doxorubicin Hydrochloride
- Drug: Etoposide
- Biological: Filgrastim
- Drug: Prednisone
- Drug: Vincristine Sulfate Liposome
- type
- EXPERIMENTAL
- label
- Arm II (RER with CR [ABVE-PC, IFRT])
- description
- Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all histologies) are eligible for this protocol if they meet the following clinical stage guidelines: * All Stage IB regardless of bulk disease * All Stage IIB regardless of bulk disease * Stage IA only with bulk disease * Stage IIA only with bulk disease * All Stage IAE, IIAE regardless of bulk disease * All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease * All Stage IVA, IVAE regardless of bulk disease * May not be staged by laparotomy alone * Surgically staged patients must also have presurgical staging * Bilirubin no greater than 1.5 times normal * SGOT or SGPT less than 2.5 times normal * Creatinine no greater than 1.5 times normal * Creatinine clearance greater than 40 mL/min * Radioisotope glomerular filtration rate greater than 70 mL/min * Shortening fraction at least 27% by echocardiogram * Ejection fraction at least 50% by MUGA * No pathologic prolongation of QTc interval on 12-lead electrocardiogram * FEV\_1/FVC greater than 60% by pulmonary function test * Pulse oximetry greater than 94% * No evidence of dyspnea at rest * No exercise intolerance * Adequate venous access * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior chemotherapy * At least 1 month since prior corticosteroids except prednisone for respiratory distress * No prior radiotherapy
References
Publications (6)
- DERIVEDKreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3. PMID 40135712
- DERIVEDCastellino 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 37505794
- DERIVEDJohnston RL, Mottok A, Chan FC, Jiang A, Diepstra A, Visser L, Telenius A, Gascoyne RD, Friedman DL, Schwartz CL, Kelly KM, Scott DW, Horton TM, Steidl C. A gene expression-based model predicts outcome in children with intermediate-risk classical Hodgkin lymphoma. Blood. 2022 Feb 10;139(6):889-893. doi: 10.1182/blood.2021011941. PMID 34662378
- DERIVEDGiulino-Roth L, Pei Q, Buxton A, Bush R, Wu Y, Wolden SL, Constine LS, Kelly KM, Schwartz CL, Friedman DL. Subsequent malignant neoplasms among children with Hodgkin lymphoma: a report from the Children's Oncology Group. Blood. 2021 Mar 18;137(11):1449-1456. doi: 10.1182/blood.2020007225. PMID 33512412
- DERIVEDWelch JJG, Schwartz CL, Higman M, Chen L, Buxton A, Kanakry JA, Kahwash SB, Hutchison RE, Friedman DL, Ambinder RF. Epstein-Barr virus DNA in serum as an early prognostic marker in children and adolescents with Hodgkin lymphoma. Blood Adv. 2017 Apr 24;1(11):681-684. doi: 10.1182/bloodadvances.2016002618. eCollection 2017 Apr 25. PMID 29296710
- DERIVEDFriedman DL, Chen L, Wolden S, Buxton A, McCarten K, FitzGerald TJ, Kessel S, De Alarcon PA, Chen AR, Kobrinsky N, Ehrlich P, Hutchison RE, Constine LS, Schwartz CL. Dose-intensive response-based chemotherapy and radiation therapy for children and adolescents with newly diagnosed intermediate-risk hodgkin lymphoma: a report from the Children's Oncology Group Study AHOD0031. J Clin Oncol. 2014 Nov 10;32(32):3651-8. doi: 10.1200/JCO.2013.52.5410. Epub 2014 Oct 13.