A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/29/2018
Start Date:November 9, 2012
End Date:March 1, 2020

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

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)


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.
We found this trial at
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