A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL

Part of paid clinical trials in La Jolla, California.

Sponsor
Gilead Sciences
Study ID
NCT01203930
Phase
PHASE2
Status
Terminated

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Idelalisib — DRUG
    Idelalisib 150 mg tablets administered orally twice daily
  • Rituximab — DRUG
    Rituximab 375 mg/m\^2 administered intravenously once weekly x 8 weeks

Study Details

This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL. This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.

Key Dates

Start date
Oct 31, 2010
Status verified
May 2017
Primary completion
Aug 31, 2015
Completion
Jun 30, 2016

Study Design

Enrollment
105 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Idelalisib
    This arm consists of 2 cohorts. Participants in Cohort 1 will receive idelalisib for up to twelve 28-day cycles (or development of unacceptable toxicity) plus rituximab (8 doses through the end of Cycle 2). Upon completion of twelve 28-cycles, participants are eligible to remain on idelalisib in a continuation protocol. Participants in Cohort 2 will receive idelalisib until disease progression or development of unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 28 Months ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, San Diego, Moores Cancer CenterLa JollaCalifornia92093-0820-
Stanford University School of MedicineStanfordCalifornia94304-
Columbia University - Herbert Irving PavilionNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sarah Cannon Research InstituteNashvilleTennessee37203-
The Universtity of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in La Jolla, CA

By research site
University of California, San Diego, Moores Cancer Center· La Jolla, CAStanford University School of Medicine· Stanford, CAColumbia University - Herbert Irving Pavilion· New York, NYMemorial Sloan Kettering Cancer Center· New York, NYSarah Cannon Research Institute· Nashville, TNThe Universtity of Texas MD Anderson Cancer Center· Houston, TX

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