Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

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 Vinblastine brentuximab vedotin 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
  • La Jolla California United States
  • Santa Monica California United States
  • Burbank California United States
  • Los Angeles California United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Millennium Pharmaceuticals, Inc.
ID
NCT01712490
Phase
Phase 3
Study Type
Interventional
Last Updated