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NCT02166463

Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma

StatusActive, Not Recruiting
PhasePhase 3
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

The 50 most recent of 498 versions: 14 with changes below, 36 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Oct 3, 2026 to Oct 14, 2027
    • Site details revised at 1 of 199 sites
  2. Study sites revised (199)
  3. Study sites revised (199)v493
  4. Study sites revised (199)v491
  5. Study sites revised (199)v490
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites revised (199)v462
  2. Study completion date: Oct 3, 2025 to Oct 3, 2026v461
  3. Study sites revised (199)v460
  4. Study sites revised (199)v459
  5. Study sites revised (199)v455
  6. Study completion date: Sep 22, 2024 to Oct 3, 2025
    • Study sites revised (199)
    v453
  7. Study sites revised (199)v452
  8. Study sites revised (199)v451
  9. Study sites revised (199)v450
  • Minor: routine updates

Endpoints

Primary

Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
Timeframe: Up to 48 months after the last enrollment

Secondary (2)

Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale

Arms and interventions

Arm I (ABVE-PC)Active comparator

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.

ARM II (Bv-AVEPC)Experimental

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.

Biologicals: Bleomycin Sulfate

Drugs: Brentuximab Vedotin, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, Methylprednisolone, Prednisone, Vincristine Sulfate

Other: Laboratory Biomarker Analysis, Pharmacological Study, Quality-of-Life Assessment, Questionnaire Administration

Sites

199 sites in 3 countries

United States 182, Canada 14, Puerto Rico 3