Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Sven De Vos (ucla)

Description

Summary

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)

Official Title

A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma, Hodgkins Lymphoma, Antibody, Monoclonal, Antibody-Drug Conjugate, Antigens, CD-30, Immunotherapy, Lymphoma, Lymphoma, Classical, ECHELON-1, Hodgkin Disease, Doxorubicin, Bleomycin, Dacarbazine, Brentuximab Vedotin, Vinblastine, A + AVD, ABVD

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • Fresno California United States
  • Santa Monica California United States
  • La Jolla California United States
  • Burbank California United States
  • Los Angeles California United States
  • Sacramento California United States
  • Long Beach California United States
  • Fullerton California United States
  • Duarte California United States
  • Stanford California United States

Lead Scientist at University of California Health

  • Sven De Vos (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 10 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT01712490
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1334 people participating
Last Updated