A Study of GDC-0199 (ABT-199) Plus MabThera/Rituxan (Rituximab) Compared with Bendamustine Plus MabThera/Rituxan (Rituximab) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 14-003328
    NCT ID: NCT02005471
    Sponsor Protocol Number: GO28667

About this study

This open-label, randomized study will compare the efficacy of GDC-0199 plus rituximab (GDC-0199+R) with bendamustine plus MabThera/Rituxan (Rituximab) (B+R) in patients with relapsed or resistant chronic lymphocytic leukemia. Patients will be randomized 1:1 into the two arms. Patients randomized to GDC-0199+R will be given GDC-0199 daily (oral, target dose 400 mg) and will receive 6 cycles of rituximab infused intravenously (IV) on Day 1 of each 28-day cycle (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2).

Patients randomized to B+R will receive 6 cycles of treatment consisting of a rituximab infusion (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2) on Day 1 and bendamustine infusions (70 mg/m2) on Days 1 and 2 of each 28-day cycle.

Patients in the GDC-0199+R arm will continue GDC-0199 treatment until disease progression or 2 years since treatment start, whichever comes first. Anticipated time on study is up to 5 years.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosis of chronic lymphocytic leukemia (CLL) per diagnostic criteria and relapsed or refractory CLL per the iwCLL guidelines.
  • Previously treated with 1-3 lines of therapy (e.g. completed ≥ two treatment cycles per therapy), including at least one standard chemotherapy-containing regimen.
  • Patients previously treated with bendamustine only if their duration of response was ≥ 24 months.
  • Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1.
  • Adequate bone marrow function.
  • Adequate renal and hepatic function.
  • Patients must use effective birth control throughout study until 1 year after rituximab treatment; female patients must not be pregnant or breast-feeding.

Exclusion Criteria:

  • Transformation of CLL to aggressive non-Hodgkin lymphoma or CNS involvement by CLL.
  • Undergone an allogenic stem cell transplant.
  • A history of significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular or hepatic disease.
  • Hepatitis B or C or known HIV positive.
  • Receiving warfarin treatment.
  • Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of study drug.
  • Received any anti-cancer or investigational therapy within 14 days prior to the first dose of study drug or has not recovered from previous therapy.
  • Received CYP3A4 inhibitors (such as fluconazole, ketoconazole and clarithromycin) or inducers (such as rifampin, carbamezapine, phenytoin, St. John's Wort) within 7 days prior to the first dose of GDC-0199.
  • Prior GDC-0199 treatment.
  • Patients with another cancer, history of another cancer considered uncured on in complete remission for < 5 years, or currently under treatment for another suspected cancer except non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated or excised and is considered resolved.
  • Malabsorption syndrome or other condition that precludes enteral route of administration.
  • Other clinically significant uncontrolled condition(s) including, but not limited to, systemic infection (viral, bacterial or fungal).
  • Vaccination with a live vaccine within 28 days prior to randomization

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Asher Chanan-Khan, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20146632

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