A Study to Compare ACP-196 and Obinutuzumab with Chlorambucil, or ACP-19 alone, with Obinutuzumab and Chlorambucil, for Patients with Previously Untreated Chronic Lymphocytic Leukemia

Overview

About this study

The purpose of this study is to compare the effectiveness of  ACP-196  combined with obinutuzumab, or ACP-196 alone compared with obinutuzumab combined with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia (CLL).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Men or women
  • ≥ 65 years of age 
  • > 18 and < 65 years of age, provided that they meet at least one of the following
    • Creatinine clearance 30 to 69 mL/min
    • 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 IWCLL 2008 criteria for requiring treatment
  • Meet the following laboratory parameters
    • ANC ≥ 750 cells/μL, or ≥ 500 cells/μL with documented bone marrow involvement, and independent of growth factor support 7 days before assessment
    • Platelet count ≥ 50,000 cells/μL, or ≥ 30,000 cells/μL with documented bone marrow involvement, and without transfusion support 7 days before assessment
      • Transfusion-dependent thrombocytopenia is excluded
    • Serum AST and ALT/SGPT ≤ 3.0 x ULN
    • Total bilirubin ≤ 1.5 x ULN
    • Estimated creatinine clearance ≥ 30 mL/min

Exclusion Criteria

  • Any prior systemic treatment for CL.
  • Known CNS lymphoma or leukemia
  • Known prolymphocytic leukemia
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Neil Kay, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Asher Alban Chanan Khan, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20301415

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