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

November 14, 2012
July 1, 2014
January 2013
December 2016   (final data collection date for primary outcome measure)
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)
Progression Free Survival [ Designated as safety issue: No ]
To evaluate the effect of the addition of GS-1101 to rituximab on progression-free survival in subjects with previously treated indolent non-Hodgkin lymphoma (iNHL)
Complete list of historical versions of study NCT01732913 on ClinicalTrials.gov Archive Site
  • 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.
  • Tumor control [ Designated as safety issue: No ]
    To evaluate the effect of the addition of GS-1101 to rituximab on the onset, magnitude, and duration of tumor control
  • Overall well-being [ Designated as safety issue: Yes ]
    To assess the effect of the addition of GS-1101 to rituximab on measures of subject well-being, including overall survival, health related quality of life, and performance status
  • Safety Profile [ Designated as safety issue: Yes ]
    To describe the overall safety profile observed with the addition of GS-1101 to rituximab characterized by the type, frequency, severity, timing of onset, duration, and relationship to study therapy of any adverse events or abnormalities of laboratory tests; serious adverse events; or adverse events leading to discontinuation of study treatment
Not Provided
Not Provided
 
A Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Indolent Non-Hodgkin's Lymphomas
  • Drug: idelalisib
    Other Names:
    • GS-1101
    • CAL-101
    • PI3K inhibitor
  • Drug: Rituximab
  • Drug: Placebo
  • 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
    Interventions:
    • Drug: idelalisib
    • 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
    Interventions:
    • Drug: Rituximab
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
375
December 2021
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Meredith Cain Meredith.cain@gilead.com
United States,   Australia,   Czech Republic,   France,   Hungary,   Israel,   Italy,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom
 
NCT01732913
GS-US-313-0124
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Henry Adewoye, MD Gilead Sciences
Gilead Sciences
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP