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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01732913
First received: November 14, 2012
Last updated: March 30, 2017
Last verified: March 2017
November 14, 2012
March 30, 2017
January 16, 2013
May 18, 2016   (Final data collection date for primary outcome measure)
Progression Free Survival
Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
Progression Free Survival
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
    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). ORR was to be assessed by an IRC.
  • Lymph Node Response Rate
    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. Lymph node response rate was to be assessed by an IRC.
  • Complete Response Rate
    Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.
  • Overall Survival
    Overall survival is defined as the interval from randomization to death from any cause.
  • Tumor control
    To evaluate the effect of the addition of GS-1101 to rituximab on the onset, magnitude, and duration of tumor control
  • Overall well-being
    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
    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

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

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Indolent Non-Hodgkin's Lymphomas
  • Drug: Placebo
    Tablets administered orally twice daily
  • Drug: 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: Idelalisib
    150 mg tablets administered orally twice daily
    Other Names:
    • GS-1101
    • CAL-101
    • Zydelig®
  • Experimental: Rituximab + idelalisib
    Participants will receive rituximab + idelalisib.
    Interventions:
    • Drug: Rituximab
    • Drug: Idelalisib
  • Placebo Comparator: Rituximab + Placebo
    Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
    Interventions:
    • Drug: Placebo
    • Drug: Rituximab
    • Drug: Idelalisib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
295
May 18, 2016
May 18, 2016   (Final data collection date for primary outcome measure)

Key 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)

Key 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Czech Republic,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Bulgaria
 
NCT01732913
GS-US-313-0124
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
March 2017

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