A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

This study has been completed.
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
First received: February 12, 2012
Last updated: May 14, 2014
Last verified: May 2014

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control, combined with rituximab, in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib or placebo and rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Idelalisib + Rituximab
Drug: Placebo + Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause.

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
    Overall response rate is defined as the proportion of participants who achieve a complete response or partial response.

  • Lymph Node Response Rate [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
    Lymph node response rate is defined as the proportion of participants who achieve a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.

  • Overall Survival [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
    Overall survival (OS) is defined as the interval from randomization to death from any cause.

  • Complete Response Rate [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
    Complete response (CR) rate is defined as the proportion of participants who achieve a CR.

Enrollment: 220
Study Start Date: April 2012
Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Idelalisib + rituximab Drug: Idelalisib + Rituximab
Idelalisib 150 mg administered orally twice daily
Other Names:
  • GS-1101
  • CAL 101
Placebo Comparator: Placebo + rituximab Drug: Placebo + Rituximab
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 administered intravenously thereafter
Other Name: Rituxan, MabThera


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy
  • Require therapy for CLL
  • Have experienced CLL progression <24 months since the completion of the last prior therapy
  • Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539512

  Show 72 Study Locations
Sponsors and Collaborators
Gilead Sciences
Study Director: Thomas Jahn, MD Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01539512     History of Changes
Other Study ID Numbers: GS-US-312-0116, 2011-005180-24
Study First Received: February 12, 2012
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
GS 1101

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014