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Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306643
First Posted: March 2, 2011
Last Update Posted: December 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose

The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL).

Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.


Condition Intervention Phase
Indolent Non-Hodgkin's Lymphoma Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma Drug: Idelalisib Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-agent Idelalisib for Previously Treated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Overall Safety of Idelalisib [ Time Frame: 30 days post last study treatment (up to 12 months) ]
    The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).

  • Clinical Response: Overall Response Rate [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]

    Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12.

    Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment.

    • CR was defined as the disappearance of all evidence of disease.
    • PR was defined the regression of measurable disease and no new sites.


Secondary Outcome Measures:
  • Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]
  • Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]
  • Changes in Concentration of Peripheral Blood Chemokines and Cytokines [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]
  • Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]

Enrollment: 18
Study Start Date: February 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idelalisib Drug: Idelalisib
Tablet(s) administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Previously treated relapsed or refractory B-cell iNHL
  • Provide written informed consent

Exclusion Criteria:

  • Pregnant or nursing
  • Active, serious infection requiring systemic therapy
  • Positive test for HIV antibodies
  • Active hepatitis B or C viral infection
  Contacts and Locations
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): NCT01306643


Locations
United States, California
Stanford Cancer Center
Palo Alto, California, United States, 94304-5548
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01306643     History of Changes
Other Study ID Numbers: 101-10
First Submitted: February 25, 2011
First Posted: March 2, 2011
Results First Submitted: August 23, 2016
Results First Posted: December 21, 2016
Last Update Posted: December 21, 2016
Last Verified: October 2016

Keywords provided by Gilead Sciences:
Indolent Non-Hodgkin's Lymphoma
Non-Hodgkin Lymphoma
iNHL
NHL
CAL-101
PI3K
Phosphatidylinositol 3-kinase
Follicular Lymphoma (FL)
Small Lymphocytic Lymphoma (SLL)
Marginal Zone Lymphoma (MZL)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Idelalisib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action