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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01539512
First received: February 12, 2012
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control 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 plus rituximab or placebo plus 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
Drug: Rituximab
Drug: Placebo to match idelalisib
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: Up to 17 months ] [ Designated as safety issue: No ]

    Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.

    Interim data is presented.



Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Up to 17 months ] [ Designated as safety issue: No ]

    Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.

    Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.

    Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.

    Interim data is presented.


  • Lymph Node Response Rate [ Time Frame: Up to 17 months ] [ Designated as safety issue: No ]

    Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.

    Interim data is presented.


  • Overall Survival [ Time Frame: Up to 17 months ] [ Designated as safety issue: No ]

    Overall survival was defined as the interval from randomization to death from any cause.

    Interim data is presented.


  • Complete Response Rate [ Time Frame: Up to 17 months ] [ Designated as safety issue: No ]

    Complete response rate was defined as the percentage of participants who achieved a complete response.

    Interim data is presented.



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
Participants will receive idelalisib plus rituximab
Drug: Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
Other Names:
  • Zydelig®
  • GS-1101
  • CAL 101
Drug: Rituximab
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter
Other Name: Rituxan®
Placebo Comparator: Placebo + rituximab
Participants will receive placebo to match idelalisib plus rituximab
Drug: Rituximab
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter
Other Name: Rituxan®
Drug: Placebo to match idelalisib
Placebo to match idelalisib administered orally twice daily

  Eligibility

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

Inclusion:

  • 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
Investigators
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
Results First Received: October 9, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
CLL
CAL-101
GS 1101
PI3K
GS-US-312-0117
idelalisib

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

ClinicalTrials.gov processed this record on October 23, 2014