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

This study is currently recruiting participants.
Verified March 2013 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01539512
First received: February 12, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of Idelalisib on the onset, magnitude, and duration of tumor control.


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:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Patient Well-Being (Health related quality of life questionnaire) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Disease related biomarkers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pharmacokinetic to measure peak plasma concentrations (Cmax) as well as the area under the plasma concentration versus time curve (AUC).

  • Incidence of Adverse Events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Health Resource Utilization [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Idelalisib + rituximab Drug: Idelalisib + Rituximab
Idelalisib 150mg taken twice daily by mouth
Other Names:
  • GS-1101
  • CAL 101
Placebo Comparator: Placebo + rituximab Drug: Placebo + Rituximab
Rituximab administered intravenously 375 mg/m2 Wk 0 and then 500 mg/m2 Wk 2,4,6,8,12,16,20
Other Name: Rituxan, MabThera

Detailed Description:

This is 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.

Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either Idelalisib or placebo. All subjects will be administered rituximab. Subjects 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.

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

Contacts
Contact: Maria Aiello 206-256-4927 Maria.Aiello@gilead.com

  Show 56 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Thomas Jahn, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01539512     History of Changes
Other Study ID Numbers: GS-US-312-0116
Study First Received: February 12, 2012
Last Updated: March 18, 2013
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
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013