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

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ClinicalTrials.gov Identifier: NCT02475681
Recruitment Status : Active, not recruiting
First Posted : June 19, 2015
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Acalabrutinib Drug: Obinutuzumab Drug: Chlorambucil Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2015
Estimated Primary Completion Date : December 2019


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. IRC-assessed objective response rate (ORR) in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]
  2. Time to next treatment (TTNT) in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]
  3. 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 ]
  4. Overall survival in Arm A versus Arm B and Arm A versus Arm C [ Time Frame: 49 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475681


  Show 147 Study Locations
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Prista Charuworn, 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
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

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