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


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. 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:

  • 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 the study team for the most up-to-date information regarding possible participation.

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


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Cancer-related trials contact form

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