A Study of Idelalisib Combined with BI 836826 for Patients with Chronic Lymphocytic Leukemia

Overview

About this study

The purpose of this study is to evaluate the safety and tolerability of the combination of idelallisib with the monoclonal antibody BI 836826 for the treatment of patients who have chronic lymphocytic leukemia that has returned or is resistant to treatment.

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

  • Diagnosis of B-cell CLL, established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria and having received at least 2 prior treatment regimens
  • CLL that warrants treatment
  • Clinically quantifiable disease burden defined as
    • For Phase Ib
      • Absolute lymphocyte count (ALC) > 5000/μL in peripheral blood
    • For Phase II 
      • At least 1 node ≥ 2 cm on computed tomography (CT) or magnetic resonance imaging (MRI)
      • Or bone marrow exam is performed at screening and demonstrates quantifiable CLL
  • Discontinuation of
    • All cytotoxic chemotherapy and anti-CD20 antibody therapy for ≥ 4 weeks
    • Alemtuzumab for ≥ 8 weeks
    • Targeted therapy for ≥ 2 weeks
    • Investigational therapy for ≥ 3 weeks before enrollment (Phase 1b) or randomization (Phase 2)
      • For relapsed CLL most recently treated with B-cell receptor (BCR) pathway inhibitors which, in the opinion of the investigator, will not tolerate waiting 3 weeks, a washout period of > 5 half-lives is allowed
      • If on a systemic corticosteroid, the dose must be stable for the previous 4 weeks
  • Eastern Cooperative Oncology Group (ECOG) score of ≤ 2

Exclusion Criteria

  • Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
  • Known presence of myelodysplastic syndrome
  • History of a non-CLL malignancy except for the following
    • Adequately treated local basal cell or squamous cell carcinoma of the skin
    • Cervical carcinoma in situ
    • Superficial bladder cancer
    • Asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to enrollment
    • Other adequately treated Stage 1 or 2 cancer currently in complete remission
    • Any other cancer that has been in complete remission for ≥ 2 years
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
  • Ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension
  • History of drug-induced pneumonitis
  • Ongoing inflammatory bowel disease
  • Ongoing alcohol or drug addiction
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing systemic immunosuppressive therapy other than corticosteroids
  • History of prior therapy with any phosphatidylinositol 3-kinase (PI3K) inhibitor (including idelalisib), or any anti-CD37 agent
  • Ongoing infection with, or treatment or prophylaxis for, CMV within the past 28 days

More information

Publications

Publications are currently not available
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CLS-20318096

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