COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT01306643
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : December 21, 2016
Last Update Posted : November 19, 2018
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

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 or disease Intervention/treatment Phase
Indolent Non-Hodgkin's Lymphoma Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma Drug: Idelalisib Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
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
Study Start Date : February 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Idelalisib Drug: Idelalisib
Tablet(s) administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Primary Outcome Measures :
  1. 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).

  2. 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 :
  1. 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) ]
  2. Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]
  3. Changes in Concentration of Peripheral Blood Chemokines and Cytokines [ Time Frame: Up to twelve 28-day cycles (maximum of 12 months) ]
  4. 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) ]

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.

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

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

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 identifier (NCT number): NCT01306643

Layout table for location information
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
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences
Layout table for additonal information
Responsible Party: Gilead Sciences Identifier: NCT01306643    
Other Study ID Numbers: 101-10
First Posted: March 2, 2011    Key Record Dates
Results First Posted: December 21, 2016
Last Update Posted: November 19, 2018
Last Verified: October 2016
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
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.
Keywords provided by Gilead Sciences:
Indolent Non-Hodgkin's Lymphoma
Non-Hodgkin Lymphoma
Phosphatidylinositol 3-kinase
Follicular Lymphoma (FL)
Small Lymphocytic Lymphoma (SLL)
Marginal Zone Lymphoma (MZL)
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action