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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 currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Acerta Pharma BV
Information provided by (Responsible Party):
Acerta Pharma BV Identifier:
First received: June 12, 2015
Last updated: September 20, 2016
Last verified: September 2016
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).

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: ACP-196
Drug: Obinutuzumab
Drug: Chlorambucil
Phase 3

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, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Time to next treatment (TTNT) in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Overall survival in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 510
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: 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.
Drug: ACP-196 Drug: Obinutuzumab
Experimental: ACP-196 Monotherapy
ACP-196 will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.
Drug: ACP-196


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT02475681

Contact: Acerta Pharma 1-888-292-9613

United States, Arizona
Arizona Oncology Associates Recruiting
Phoenix, Arizona, United States, 85016
Contact    602-277-4868      
United States, California
Pacific Cancer Medical Center Inc. Recruiting
Anaheim, California, United States, 92801
Contact    714-999-1465      
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact    720-848-8026      
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80218
Contact    303-388-4876      
United States, Illinois
Illinois Cancer Specialists Recruiting
Niles, Illinois, United States, 60714
Contact    847-827-9060      
United States, Maryland
Maryland Oncology Hematology, P.A. Recruiting
Columbia, Maryland, United States, 21044
Contact    410-964-2212      
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Contact    330-365-2135      
United States, Oregon
Willamette Valley Cancer Institute and Research Center Recruiting
Springfield, Oregon, United States, 97477
Contact    541-741-3451      
United States, Texas
Texas Oncology - Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact    972-566-4291      
Texas Oncology - Dallas Presbyterian Hospital Recruiting
Dallas, Texas, United States, 75231
Contact    214-265-2080      
Cancer Care Centers of South Texas Recruiting
New Braunfels, Texas, United States, 78130
Contact    830-643-1762      
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78217
Contact    210-656-7177      
Texas Oncology - Deke Slayton Cancer Center Recruiting
Webster, Texas, United States, 77598
Contact    281-332-7505      
United States, Virginia
Oncology and Hematology Associates of Southwest Virginia, Inc. Recruiting
Roanoke, Virginia, United States, 24014
Contact    540-982-0237      
United States, Washington
Yakima Valley Memorial Hospital / North Star Lodge Recruiting
Yakima, Washington, United States, 98902
Contact    509-574-3493      
Sponsors and Collaborators
Acerta Pharma BV
Study Director: Priti Patel, MD Acerta Pharma BV
  More Information

Responsible Party: Acerta Pharma BV Identifier: NCT02475681     History of Changes
Other Study ID Numbers: ACE-CL-007 
Study First Received: June 12, 2015
Last Updated: September 20, 2016
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ethics Committee
Brazil: National Health Surveillance Agency
Canada: Institutional Review Board
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Chile: Ministry of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombia: Ethics Committee
France: Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Hungary: Scientific and Medical Research Council Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
New Zealand: Medsafe
New Zealand: Health and Disability Ethics Committees
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Sweden: Central Ethical Review Board
Sweden: Medical Products Agency
United Kingdom: National Health Service
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on October 26, 2016