Clinical trial · Interventional
Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma
A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease
- 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 combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's 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 more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells.
Conditions
Conditions (6)
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 Favorable Prognosis Hodgkin Lymphoma | Childhood Favorable Prognosis Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Childhood Lymphocyte Depletion Hodgkin Lymphoma | Hodgkin Lymphoma | PROBABILISTIC | 0.70 |
| Childhood Mixed Cellularity Hodgkin Lymphoma | Childhood Mixed Cellularity Classic Hodgkin Lymphoma | ALIAS | 0.90 |
| Childhood Nodular Sclerosis 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 | CURATED_BROADER | 0.78 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
- description
- Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 \& 2, Vincristine sulfate IV (1.4 mg/m2 \[max 2.8 mg\]) Days 1 \& 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 \& 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.
- interventionNames
- Radiation: radiation therapy
- Drug: doxorubicin hydrochloride
- Drug: vincristine sulfate
- Drug: prednisone
- Drug: cyclophosphamide
- Drug: ifosfamide
- Drug: vinorelbine tartrate
- Drug: dexamethasone
- Drug: etoposide phosphate
- Drug: cisplatin
- Drug: cytarabine
- Biological: filgrastim
Primary outcomes (3)
- measure
- Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed Hodgkin's lymphoma meeting the following criteria: * Newly diagnosed disease * Stage IA OR stage IIA without bulky disease * No lymphocyte-predominant histology * Staging on this study will be determined by the clinical stage; surgical staging is strongly discouraged, except for the rare situation of equivocal imaging studies below the diaphragm * Patients may not have received any previous chemotherapy or radiation therapy; patients may not have received systemic corticosteroids within 30 days of enrollment on this protocol; steroids used for treatment of contrast agent allergy required for computed tomography (CT) scans are acceptable * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^3 * Total bilirubin =\< 1.5 x normal * Alanine (ALT) =\< 2.5 x normal * Shortening fraction \>= 27% by echocardiogram OR ejection fraction \>= 50% by multi-gated acquisition (MUGA) * No pathologic prolongation of QTc interval on 12-lead electrocardiography (ECG) * Female patients of childbearing potential must have a negative pregnancy test * Lactating females must agree that they will not breastfeed a child while on this study * Fertile patients must use effective contraception * Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * 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
References
Publications (2)
- 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
- DERIVEDParekh A, Keller FG, McCarten KM, Kessel S, Cho S, Pei Q, Wu Y, Castellino SM, Constine LS, Schwartz CL, Hodgson D, Kelly KM, Hoppe BS. Targeted radiotherapy for early-stage, low-risk pediatric Hodgkin lymphoma slow early responders: a COG AHOD0431 analysis. Blood. 2022 Sep 8;140(10):1086-1093. doi: 10.1182/blood.2022016098. PMID 35763667