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 September 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01732913
First received: November 14, 2012
Last updated: September 10, 2014
Last verified: September 2014

November 14, 2012
September 10, 2014
January 2013
October 2018   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
Progression-free survival (PFS) is defined as the interval from initial randomization to the earlier of the first documentation of definitive iNHL disease progression or death from any cause; definitive iNHL disease progression is progression based on standard criteria.
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: Up to 8 years ] [ 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 8 years ] [ 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 8 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the interval from randomization to death from any cause.
  • Complete Response Rate [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    Complete response rate is defined as the proportion of participants 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
 
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

This study is to evaluate the effect of the addition of idelalisib (GS-1101) to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

Not Provided
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
    Idelalisib tablet(s) administered orally
    Other Names:
    • GS-1101
    • CAL-101
    • Zydelig®
  • Drug: Rituximab
    Rituximab 375 mg/m^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
    Other Names:
    • Rituxan®
    • MabThera®
  • Drug: Placebo to match idelalisib
    Placebo to match idelalisib tablet(s) administered orally
  • Experimental: Rituximab+idelalisib
    Participants will receive rituximab plus idelalisib 150 mg twice daily during the primary study. Participants who develop iNHL disease progression in the primary study and meet the entry criteria for the double-blind extension phase will receive idelalisib 300 mg twice daily during the extension phase.
    Interventions:
    • Drug: Idelalisib
    • Drug: Rituximab
  • Placebo Comparator: Rituximab+Placebo
    Participants will receive rituximab plus placebo to match idelalisib twice daily during the primary study. Participants who develop iNHL disease progression in the primary study and meet the entry criteria for the double-blind extension phase will receive idelalisib 150 mg twice daily during the extension phase.
    Interventions:
    • Drug: Idelalisib
    • Drug: Rituximab
    • Drug: Placebo to match idelalisib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
375
October 2023
October 2018   (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 10^9/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:

  • History of lymphoid malignancy other than those allowed per inclusion criteria
  • 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: Gilead Study Team GS-US-313-0124_0125@gilead.com
Australia,   Korea, Republic of,   Italy,   United Kingdom,   United States,   Poland,   France,   Hungary,   Czech Republic,   Russian Federation,   Israel,   Spain,   Sweden,   Singapore
 
NCT01732913
GS-US-313-0124
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Henry Adewoye, MD Gilead Sciences
Gilead Sciences
September 2014

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