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Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT02258529
Recruitment Status : Terminated
First Posted : October 7, 2014
Results First Posted : May 18, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma (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 those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.


Condition or disease Intervention/treatment Phase
Follicular Lymphoma Small Lymphocytic Lymphoma Drug: Idelalisib Biological: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Actual Study Start Date : September 14, 2015
Actual Primary Completion Date : April 12, 2016
Actual Study Completion Date : May 3, 2016


Arm Intervention/treatment
Experimental: Idelalisib + rituximab
Idelalisib + rituximab for up to 104 weeks
Drug: Idelalisib
150 tablets administered orally twice daily
Other Names:
  • Zydelig®
  • GS-1101

Biological: Rituximab
375 mg/m^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Other Names:
  • Rituxan®
  • MabThera®




Primary Outcome Measures :
  1. Overall Response Rate
    Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).


Secondary Outcome Measures :
  1. Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death [ Time Frame: Up to 24 weeks plus 30 days ]
  2. Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings [ Time Frame: Up to 24 weeks plus 30 days ]
    The rate of Grade ≥ 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.

  3. Idelalisib Trough and Peak Plasma Concentrations [ Time Frame: Predose and 1.5 hour postdose at Weeks 2, 4, and 12 ]
  4. Time to Response
    Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.

  5. Duration of Response
    Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.

  6. Progression-Free Survival
    Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.

  7. Overall Survival
    Overall survival was defined as the interval from enrollment to death from any cause.

  8. Changes in Health-Related Quality of Life
    Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of B-cell lymphoma
  • No previous systemic treatment for lymphoma
  • Subject demonstrates need for treatment for lymphoma
  • Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
  • Adequate performance status
  • Required baseline laboratory data within protocol-specified parameters

Key Exclusion Criteria:

  • Known history of transformed lymphoma or diffuse large cell lymphoid malignancy
  • Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
  • Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
  • Ongoing inflammatory bowel disease
  • Known human immunodeficiency virus (HIV) infection
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258529


Locations
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United States, California
Pacific Shores Medical Group
Long Beach, California, United States, 90813
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
United States, Maryland
St. Agnes Hospital
Baltimore, Maryland, United States, 21229
United States, South Dakota
Prarie Lakes Health Care Systems, Inc.
Watertown, South Dakota, United States, 57201
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
United States, Washington
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02258529     History of Changes
Other Study ID Numbers: GS-US-313-1414
First Posted: October 7, 2014    Key Record Dates
Results First Posted: May 18, 2017
Last Update Posted: May 14, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Cancer
Indolent Non-Hodgkin Lymphoma
FL
SLL

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Rituximab
Idelalisib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action