A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

Sponsor: Takeda

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01712490

Patient View

This phase 3 study evaluates mPFS in advanced classical Hodgkin lymphoma using A+AVD versus ABVD. Eligible participants are treatment-naïve with Stage III/IV HL, confirmed by WHO classification, ECOG ≤2, and measurable disease. Interventions include brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine, administered via IV infusion on Days 1 and 15 of each 28-day cycle.

Patient Parameters

Program Overview

This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)

Eligibility Criteria

Inclusion Criteria

  1. Treatment-naïve participants with Ann Arbor Stage III or IV HL.
  2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
  3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.
  4. Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.

Exclusion Criteria

  1. Nodular lymphocyte predominant Hodgkin lymphoma.
  2. Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
  3. Sensory or motor peripheral neuropathy.
  4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
  5. Known human immunodeficiency virus (HIV) positive.
  6. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.

Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.

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