A Study Evaluating the Efficacy and Safety of Idelalisib(GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (Bridalveil)

This study is currently recruiting participants.
Verified April 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01732926
First received: November 14, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate the effect of idelalisib (GS-1101) on the onset, magnitude, and duration of tumor control.


Condition Intervention Phase
Indolent Non-Hodgkin's Lymphomas
Drug: Idelalisib orally 150 mg BID
Drug: Placebo orally 150 mg BID
Drug: Rituximab IV 375 mg/m2 every 28 days for 4 cycles
Drug: Bendamustine 90 mg/m2 for 2 consecutive days every 28 days for 4 cycles
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 Indolent Non-Hodgkin Lymphomas

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: From randomization to 51 months ] [ Designated as safety issue: No ]
    Progression-free survival is defined as the interval from randomization to the earlier of the first documentation of definitive iNHL disease progression or death from any cause.


Secondary Outcome Measures:
  • Complete Response Rate [ Time Frame: From randomization to 51 months ] [ Designated as safety issue: No ]
    Complete response rate is defined as the proportion of subjects who achieve a complete response.

  • Overall Response Rate [ Time Frame: From randomization to 51 months ] [ Designated as safety issue: No ]
    Overall response rate (ORR) is defined as the proportion of subjects who achieve a complete response or partial response (or very good partial response or minor response for subjects with Waldenstrom's).

  • Lymph Node Response Rate [ Time Frame: From randomization to 51 months ] [ Designated as safety issue: No ]
    Lymph node response rate is defined as the proportion of subjects who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions.

  • Overall Survival [ Time Frame: From randomization to 51 months ] [ Designated as safety issue: No ]
    Overall survival is defined as the interval from randomization to death from any cause.


Estimated Enrollment: 450
Study Start Date: January 2013
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Rituximab IV 375mg/m2 every 28 days for 4 cycles; bendamustine 90mg/m2 for 2 consecutive days every 28 days for 4 cycles; idelalisib (GS-1101) orally 150mg BID
Drug: Idelalisib orally 150 mg BID
Other Names:
  • CAL-101
  • GS-1101
Drug: Placebo orally 150 mg BID Drug: Rituximab IV 375 mg/m2 every 28 days for 4 cycles
Experimental: Arm B
Rituximab IV 375mg/m2 every 28 days for 4 cycles; bendamustine 90mg/m2 for 2 consecutive days every 28 days for 4 cycles; Placebo orally BID
Drug: Idelalisib orally 150 mg BID
Other Names:
  • CAL-101
  • GS-1101
Drug: Placebo orally 150 mg BID Drug: Bendamustine 90 mg/m2 for 2 consecutive days every 28 days for 4 cycles

Detailed Description:

This is a Phase 3, multicenter, 2-arm, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor idelalisib (GS-1101) in combination with bendamustine and rituximab for previously treated indolent non-Hodgkin lymphomas.

Eligible subjects will be randomized with a 2:1 allocation to Arm A (idelalisib + bendamustine + rituximab) vs. Arm B (placebo + bendamustine + rituximab).

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following

    1. Follicular lymphoma (FL) Grade 1, 2, or 3a
    2. Small lymphocytic lymphoma (SLL)
    3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
    4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Exclusion Criteria:

  • Known histological transformation to an aggressive lymphoma
  • Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B , alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
  • Prior treatment with bendamustine that was not effective.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732926

Contacts
Contact: Meredith Cain Meredith.cain@gilead.com

  Show 150 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Steve Abella, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01732926     History of Changes
Other Study ID Numbers: GS-US-313-0125
Study First Received: November 14, 2012
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
iNHL
indolent NHL
follicular lymphoma
CAL-101
rituximab
bendamustine
small lymphocytic lymphoma
lymphoplasmacytoid lymphoma
Waldenstrom macroglobulinemia
LPL
WM
Marginal zone lymphoma
MZL
SLL
FL
GS-1101
PI3K inhibitor
idelalisib

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
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 April 17, 2014