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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV
ClinicalTrials.gov Identifier:
NCT02475681
First received: June 12, 2015
Last updated: February 14, 2017
Last verified: February 2017
  Purpose
This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL).

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Acalabrutinib
Drug: Obinutuzumab
Drug: Chlorambucil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Acerta Pharma BV:

Primary Outcome Measures:
  • Progression-free survival in Arm A compared to Arm B [ Time Frame: 49 months ]

Secondary Outcome Measures:
  • IRC-assessed objective response rate (ORR) in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]
  • Time to next treatment (TTNT) in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]
  • Incidence of adverse events, serious adverse events and changes in laboratory measurements in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]
  • Overall survival in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]

Enrollment: 535
Study Start Date: June 2015
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
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.
Drug: Obinutuzumab Drug: Chlorambucil
Experimental: Acalabrutinib 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.
Drug: Acalabrutinib Drug: Obinutuzumab
Experimental: Acalabrutinib Monotherapy
Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.
Drug: Acalabrutinib

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02475681

Locations
United States, Arizona
Arizona Oncology Associates
Phoenix, Arizona, United States, 85016
United States, California
Pacific Cancer Medical Center Inc.
Anaheim, California, United States, 92801
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Illinois
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
United States, Maryland
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Oregon
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States, 97477
United States, Texas
Texas Oncology - Medical City Dallas
Dallas, Texas, United States, 75230
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Cancer Care Centers of South Texas
New Braunfels, Texas, United States, 78130
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, United States, 77598
United States, Virginia
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
United States, Washington
Yakima Valley Memorial Hospital / North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Priti Patel, MD Acerta Pharma BV
  More Information

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02475681     History of Changes
Other Study ID Numbers: ACE-CL-007
Study First Received: June 12, 2015
Last Updated: February 14, 2017

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Chlorambucil
Obinutuzumab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 25, 2017