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A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and 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:
NCT01569295
First received: March 27, 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
Drug: Rituximab
Drug: Bendamustine
Drug: Placebo
 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 Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

Resource links provided by NLM:

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 ]
    Peak Plasma Concentration (Cmax)

  • Incidence of Adverse Events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Health Resource Utilization (utility measure questionnaire) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Trough Plasma Concentration (Cmin)


Estimated Enrollment: 390
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Idelalisib + bendamustine/rituximab Drug: Idelalisib
Idelalisib 150 mg taken twice daily by mouth
Other Names:
  • GS-1101
  • CAL 101
  • CAL-101
Drug: Rituximab
Rituximab 375 mg/m2 Wk 0 and then 500 mg/m2 Wk 4,8,12,16,and 20 administered intravenously
Other Name: Rituxan, MabThera
Drug: Bendamustine
Bendamustine 70 mg/mg2/day on 2 consecutive days at Wk 0,4,8,12,16, and 20 administered intravenously
Other Name: Ribomustin, Treanda, SDX-105
Placebo Comparator: Placebo + bendamustine/rituximab Drug: Rituximab
Rituximab 375 mg/m2 Wk 0 and then 500 mg/m2 Wk 4,8,12,16,and 20 administered intravenously
Other Name: Rituxan, MabThera
Drug: Bendamustine
Bendamustine 70 mg/mg2/day on 2 consecutive days at Wk 0,4,8,12,16, and 20 administered intravenously
Other Name: Ribomustin, Treanda, SDX-105
Drug: Placebo
Placebo taken twice daily by mouth

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 Bendamustine and 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 bendamustine and rituximab.

  Eligibility

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

Inclusion:

  • Previously treated recurrent CLL
  • Measurable lymphadenopathy
  • Requires therapy for CLL
  • Has experienced CLL progression <36 months since the completion of the last prior therapy

Exclusion:

  • Recent history of a major non-CLL malignancy
  • Evidence of an ongoing infection
  • CLL refractory to bendamustine
  • Concurrent participation in another therapeutic clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569295

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

  Show 59 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: NCT01569295     History of Changes
Other Study ID Numbers: GS-US-312-0115
Study First Received: March 27, 2012
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
CLL
CAL 101
CAL-101
GS 1101
GS-1101
PI3K
 Rituxan
Rituximab
Bendamustine
Leukemia
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
Bendamustine
 Rituximab
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 18, 2013