Clinical Trials /

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

NCT02475681

Description:

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).

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: ACE-CL-007
  • NCT ID: NCT02475681

Trial Conditions

  • Chronic Lymphocytic Leukemia

Trial Interventions

DrugSynonymsArms
ACP-196ACP-196 in Combination with Obinutuzumab
ObinutuzumabObinutuzumab in Combination with Chlorambucil
ChlorambucilObinutuzumab in Combination with Chlorambucil

Trial Purpose

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).

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
Obinutuzumab in Combination with ChlorambucilActive ComparatorObinutuzumab 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.
    • Obinutuzumab
    • Chlorambucil
ACP-196 in Combination with ObinutuzumabExperimentalObinutuzumab 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.
  • ACP-196
  • Obinutuzumab
    ACP-196 MonotherapyExperimentalACP-196 will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.
    • ACP-196

      Eligibility 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.

      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Both
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Progression-free survival in Arm A compared to Arm B
      Time Frame:49 months
      Safety Issue:No
      Description:

      Secondary Outcome Measures

      Measure:IRC-assessed objective response rate (ORR) in Arm A versus Arm B and Arm A versus Arm C
      Time Frame:49 months
      Safety Issue:No
      Description:
      Measure:Time to next treatment (TTNT) in Arm A versus Arm B and Arm A versus Arm C
      Time Frame:49 months
      Safety Issue:No
      Description:
      Measure: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
      Safety Issue:Yes
      Description:
      Measure:Overall survival in Arm A versus Arm B and Arm A versus Arm C
      Time Frame:49 months
      Safety Issue:No
      Description:

      Trial Keywords