Clinical trial · Interventional
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults
- 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 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.
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 |
|---|---|---|---|
| Ann Arbor Stage IIB Hodgkin Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage IIIB Hodgkin Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage IVA Hodgkin Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage IVB Hodgkin Lymphoma | — | UNRESOLVED | — |
| Childhood Hodgkin Lymphoma | Childhood Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Classic Hodgkin Lymphoma | Classic Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin Sulfate | Biological | Bleomycin | ALIAS |
| Brentuximab Vedotin | Drug | Brentuximab Vedotin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Methylprednisolone | Drug | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (ABVE-PC)
- description
- 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.
- interventionNames
- Biological: Bleomycin Sulfate
- Drug: Cyclophosphamide
- Drug: Doxorubicin Hydrochloride
- Drug: Etoposide
- Other: Laboratory Biomarker Analysis
- Drug: Methylprednisolone
- Other: Pharmacological Study
- Drug: Prednisone
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Drug: Vincristine Sulfate
- type
- EXPERIMENTAL
- label
- ARM II (Bv-AVEPC)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 22 Years
Show eligibility criteria text
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 eligibleReferences
Publications (9)
- DERIVEDToner 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. PMID 40990939
- DERIVEDWilliams 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. PMID 40700618
- 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
- DERIVEDPabari 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. PMID 39058968
- DERIVEDWilliams 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. PMID 39058966
- DERIVEDParsons 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.