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
  Purpose

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).


Condition Intervention Phase
Indolent Non-Hodgkin's Lymphomas
Drug: Idelalisib
Drug: Rituximab
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 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 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 375
Study Start Date: January 2013
Estimated Study Completion Date: October 2023
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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®
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.
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

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

  Show 129 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: September 10, 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 September 14, 2014