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

  • STATUS
    Recruiting
  • sponsor
    Acerta Pharma
Updated on 25 March 2021

Summary

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

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.

Contact: 1-888-292-9613 or acertamc@dlss.com

Sponsor:
Acerta Pharma BV

Study Director: Jane Huang, MD Acerta Pharma BV

Details
Clinical Study IdentifierTX143438
SponsorAcerta Pharma
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women ≥ 18 years of age
ECOG performance status of 0 to 2
Diagnosis of CLL
Must have ≥ 1 of the following high-risk prognostic factors
Presence of 17p del by central laboratory
Presence of 11q del by central laboratory
Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment
Must have received ≥ 1 prior therapies for CLL
Meet the following laboratory parameters
ANC ≥ 750 cells/µL or ≥ 500 cells/µL in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment
Platelet count ≥ 30,000 cells/µL without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded
Serum AST/SGOT and ALT/SGPT ≤ 3.0 x ULN
Total bilirubin ≤ 1.5 x ULN
Estimated creatinine clearance ≥ 30 mL/min

Exclusion Criteria

Known CNS lymphoma or leukemia
Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
Prior exposure to ibrutinib or to a BCR inhibitor or a BCL-2 inhibitor
Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug
Prior radio- or toxin-conjugated antibody therapy
Prior allogeneic stem cell or autologous transplant
Major surgery within 4 weeks before first dose of study drug
Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence
Significant cardiovascular disease within 6 months of Screening
Known history of infection with HIV
History of stroke or intracranial hemorrhage within 6 months before randomization
History of bleeding diathesis
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug
Requires treatment with a strong CYP3A inhibitor/inducer
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