Last updated on November 2017

ACE-CL-007: Study of Obinutuzumab + Chlorambucil, ACP-196 + Obinutuzumab, and ACP-196 Monotherapy in Subjects With Previously Untreated CLL


Brief description of study

ACE-CL-007: Study of Obinutuzumab + Chlorambucil, ACP-196 + Obinutuzumab, and ACP-196 Monotherapy in Subjects With Previously Untreated CLL

Detailed Study Description

This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with ACP-196 in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL).

Arms Assigned Interventions
Active Comparator: Obinutuzumab in Combination with Chlorambucil
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6.

Experimental: ACP-196 in Combination with Obinutuzumab
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles. ACP-196 will be orally administered starting on Cycle 1 Day 1. Daily administration of ACP-196 will continue until disease progression or unacceptable toxicity.

Experimental: ACP-196 Monotherapy
ACP-196 will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, ACP-196 in Combination With Obinutuzumab, and ACP-196 Monotherapy in Subjects With Previously Untreated CLL.

Clinical Study Identifier: TX7813

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Borbala Szekely

Debreceni Egyetem Klinikai Kozpont
Debrecen, XX Hungary
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Tammy Himes

Indiana University Health Arnett Inc
Lafayette, IN USA
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Theresa De Man

Frankston Hospital
Frankston, XX Australia
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