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AHOD1331

A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults

Phase 3N = 600NCT02166463

Population
Patients 2 to 21 years of age with previously untreated Hodgkin lymphoma of stage IIB with bulk tumour, or stage IIIB, IVA or IVB; 600 enrolled and 587 eligible.
Design
Open-label, multicentre, randomised phase 3 trial in 153 institutions: five 21-day cycles of brentuximab vedotin with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide versus a standard pediatric regimen that includes bleomycin. Involved-site radiation therapy after the fifth cycle for slow-responding lesions (PET-CT score of 4 or 5 after two cycles) and for large mediastinal adenopathy at diagnosis. Primary endpoint: event-free survival (progression, relapse, second malignant neoplasm or death).
Primary endpoint
EFS
Arms
  • Brentuximab vedotin group (experimental, n = 298): Brentuximab vedotin with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide, five 21-day cycles
  • Standard-care group (control, n = 289): Doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide, five 21-day cycles
People
Castellino SM
EFSHR 0.41 (95% CI 0.25–0.67)Δ 36-month EFS+9.6 pointsΔ 36-month OS+0.8 points
Show the numbers
Results reported for AHOD1331
EndpointAnalysisBrentuximab vedotin groupStandard-care groupEffect
EFSITT: eligible patients (587 of 600 enrolled)primarymedian follow-up 42.1 monthsCastellino 202292.1% at 3 y (88.4–94.7%)82.5% at 3 y (77.4–86.5%)HR 0.41 (95% CI 0.25–0.67)P<0.001Hazard ratio is for event or death. Involved-site radiation therapy was given to 53.4% (brentuximab vedotin) and 56.8% (standard care).
OSITT: eligible patients (587 of 600 enrolled)primarymedian follow-up 42.1 monthsCastellino 202299.3% at 3 y (97.3–99.8%)98.5% at 3 y (96.0–99.4%)—
Results reported for AHOD1331
EndpointAnalysisBrentuximab vedotin groupStandard-care groupEffect
EFSITT: eligible patients (587 of 600 enrolled)primarymedian follow-up 42.1 monthsCastellino 202292.1% at 3 y (88.4–94.7%)82.5% at 3 y (77.4–86.5%)HR 0.41 (95% CI 0.25–0.67)P<0.001Hazard ratio is for event or death. Involved-site radiation therapy was given to 53.4% (brentuximab vedotin) and 56.8% (standard care).
OSITT: eligible patients (587 of 600 enrolled)primarymedian follow-up 42.1 monthsCastellino 202299.3% at 3 y (97.3–99.8%)98.5% at 3 y (96.0–99.4%)—
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
EFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
EFS0.410.25–0.67
Primary publication: Castellino SM, Pei Q, Parsons SK, Hodgson D, McCarten K, Horton T, et al. Brentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkin's Lymphoma. N Engl J Med. 2022;387(18):1649-1660. PubMedDOI

Appears in

Sources

  1. Castellino SM, Pei Q, Parsons SK, Hodgson D, McCarten K, Horton T, et al. Brentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkin's Lymphoma. N Engl J Med. 2022;387(18):1649-1660.

    PubMedDOI