Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/10/2016
Start Date:June 2015
Contact:Acerta Pharma
Phone:1-888-292-9613

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A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL

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


Inclusion Criteria:

- Men and women: ≥ 65 years of age OR > 18 and < 65 years of age, provided that they
meet at least one of the following criteria:

1. Creatinine clearance 30 to 69 mL/min.

2. A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric.

- ECOG performance status of 0, 1, or 2.

- Diagnosis of CD20+ CLL.

- Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring
treatment.

- Meet the following laboratory parameters:

1. 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.

2. Platelet count ≥ 50,000 cells/μL, or ≥ 30,000 cells/μL in subjects with
documented bone marrow involvement, and without transfusion support 7 days
before assessment. Subjects with transfusion-dependent thrombocytopenia are
excluded.

3. Serum AST and ALT/SGPT ≤ 3.0 x ULN.

4. Total bilirubin ≤ 1.5 x ULN.

5. Estimated creatinine clearance ≥ 30 mL/min.

Exclusion Criteria:

- Any prior systemic treatment for CLL.

- 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.

- 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.

- Known history of a bleeding diathesis.

- Requires or receiving anticoagulation with warfarin or equivalent vitamin K
antagonists within 7 days of first dose of study drug.
We found this trial at
15
sites
100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Phone: 210-656-7177
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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Anaheim, California 92801
Phone: 714-999-1465
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Aurora, Colorado 80045
Phone: 720-848-8026
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Phone: 330-365-2135
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Columbia, Maryland 21044
Phone: 410-964-2212
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Dallas, Texas 75201
Phone: 972-566-4291
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Dallas, Texas 75231
Phone: 214-265-2080
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Denver, Colorado 80218
Phone: 303-388-4876
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New Braunfels, Texas 78130
Phone: 830-643-1762
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Niles, Illinois 60714
Phone: 847-827-9060
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Phoenix, Arizona 85016
Phone: 602-277-4868
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Roanoke, Virginia 24014
Phone: 540-982-0237
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Springfield, Oregon 97477
Phone: 541-741-3451
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Webster, Texas 77598
Phone: 281-332-7505
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2811 Tieton Drive
Yakima, Washington 98902
Phone: 509-574-3493
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