Clinical trial · Interventional
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
- 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 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.
Conditions
Conditions (3)
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 Nodular Lymphocyte Predominant Hodgkin Lymphoma | Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma | ALIAS | 0.90 |
| Stage III Childhood Hodgkin Lymphoma | Childhood Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage IV Childhood Hodgkin Lymphoma | Childhood Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin sulfate | Biological | Bleomycin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| liposomal vincristine sulfate | Drug | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Regimen I (consolidation therapy)
- description
- Patients 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.
- interventionNames
- Biological: bleomycin sulfate
- Drug: doxorubicin hydrochloride
- Drug: liposomal vincristine sulfate
- Drug: cyclophosphamide
- Drug: etoposide phosphate
- Drug: prednisone
- Biological: filgrastim
- type
- EXPERIMENTAL
- label
- Regimen II (consolidation therapy)
- description
- Patients 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* 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:
* 0.4 mg/dL (1 to 5 months)
* 0.5 mg/dL (6 to 11 months)
* 0.6 mg/dL (12 to 23 months)
* 0.8 mg/dL (2 to 5 years)
* 1 mg/dL (6 to 9 years)
* 1.2 mg/dL (10 to 12 years)
* 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)
* 1.7 mg/dL (males) or 1.4 mg/dL (females) (≥ 16 years)
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
* AST or ALT \< 2.5 times ULN for age
* Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by MUGA (unless due to large mediastinal mass from HL)
* FEV\_1/FVC \> 60% by pulmonary function tests (PFT) (unless due to large mediastinal mass fromHL)
* For children who are unable to cooperate for PFTs, the criteria are:
* No evidence of dyspnea at rest
* No exercise intolerance
* Pulse oximetry \> 92% on room air
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pathologic prolongation of QTc interval (\> 450 milliseconds) on 12-lead ECG
* No prior chemotherapy, biological response modifiers (e.g., monoclonal antibody therapy), or radiotherapy
* At least 28 days since prior corticosteroids except for emergent treatment for respiratory distress or spinal cord compression, or for treatment of allergy to contrast agent required for CT scan
* No other concurrent cancer chemotherapy or immunomodulating agents (including steroids)
* Concurrent corticosteroid therapy as treatment or prophylaxis for anaphylactic reactions allowed
* No concurrent pegfilgrastimReferences
Publications (2)
- DERIVEDTie 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 39969278
- 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