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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. (see Contacts and Locations)
Verified October 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01732926
First received: November 14, 2012
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

This study will evaluate the the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).


Condition Intervention Phase
Indolent Non-Hodgkin's Lymphomas
Drug: Idelalisib
Drug: Rituximab
Drug: Bendamustine
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 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: Up 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: Up to 51 months ] [ Designated as safety issue: No ]
    Complete response rate is defined as the proportion of participants who achieve a complete response.

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

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

  • Overall Survival [ Time Frame: Up to 10 years ] [ 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: Rituximab+bendamustine+idelalisib
Participants will receive rituximab+bendamustine+idelalisib.
Drug: Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
Other Names:
  • Zydelig®
  • CAL-101
  • GS-1101
Drug: Rituximab
Rituximab 375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
Other Names:
  • Rituxan®
  • MabThera®
Drug: Bendamustine
Bendamustine 90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
Other Name: Treanda®
Experimental: Rituximab+bendamustine+placebo to match idelalisib
Participants will receive rituximab+bendamustine+placebo to match idelalisib.
Drug: Rituximab
Rituximab 375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
Other Names:
  • Rituxan®
  • MabThera®
Drug: Bendamustine
Bendamustine 90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
Other Name: Treanda®
Drug: Placebo to match idelalisib
Placebo to match idelalisib tablet administered orally twice daily

  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
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: NCT01732926

Contacts
Contact: Gilead Study Team GS-US-313-0124_0125@gilead.com

  Show 191 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Wayne Godfrey, 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, 2012-004034-42
Study First Received: November 14, 2012
Last Updated: October 23, 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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bendamustine
Nitrogen Mustard Compounds
Rituximab
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014