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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01732913
First received: November 14, 2012
Last updated: July 1, 2014
Last verified: July 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
Drug: Rituximab
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 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: Every 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the effect of the addition of idelalisib (GS-1101) to rituximab on progression-free survival in subjects with previously treated indolent non-Hodgkin lymphoma (iNHL)


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Assessed every 12 weeks until progression ] [ 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 patients with Waldenstrom's).

  • Lymph Node Response [ Time Frame: Baseline to end of study ] [ 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: Baseline to end of study ] [ Designated as safety issue: No ]
    Overall survival is defined as the interval from randomization to death from any cause.

  • Complete Response Rate [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
    Complete response is defined as the proportion of patients who achieve a complete response.


Estimated Enrollment: 375
Study Start Date: January 2013
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen A
Rituximab IV 375 mg/m2 weekly x 4, then every 8 weeks x 4; idelalisib (GS-1101) orally 150 mg BID until disease progression
Drug: idelalisib
Other Names:
  • GS-1101
  • CAL-101
  • PI3K inhibitor
Drug: Rituximab
Active Comparator: Regimen B
Rituximab IV 375 mg/m2 weekly x 4, then every 8 weeks x 4; Placebo orally 150 mg BID until disease progression
Drug: Rituximab Drug: Placebo

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 Rituximab for previously treated indolent non-hodgkin lymphomas.

Eligible subjects will be randomized with a 2:1 allocation to Regimen A vs. Regimen B.

  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) with absolute lymphocyte count <5 x 109/L at the time of diagnosis
    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.
  • Received previous treatment with rituximab 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: NCT01732913

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

  Show 123 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Henry Adewoye, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01732913     History of Changes
Other Study ID Numbers: GS-US-313-0124
Study First Received: November 14, 2012
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 31, 2014