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

Contact Investigators or Research Sites near you

Start Over

Borbala Szekely

Debreceni Egyetem Klinikai Kozpont
Debrecen, XX Hungary

Tammy Himes

Indiana University Health Arnett Inc
Lafayette, IN USA

Theresa De Man

Frankston Hospital
Frankston, XX Australia