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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.
Information provided by (Responsible Party):
Gilead Sciences Identifier:
First received: February 25, 2011
Last updated: October 14, 2015
Last verified: October 2015

This Phase 1/2, open-label, single-arm, efficacy, safety, and pharmacodynamic study is to evaluate safety and efficacy of idelalisib (GS-1101, CAL-101) in patients 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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-agent CAL-101 for Previously Teated 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:
  • Evaluate the overall safety of idelalisib [ Time Frame: Every 2-4 weeks ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by assessing extent of exposure to idelalisib, adverse events, clinical laboratory data, and vital signs

  • Clinical response rate during treatment with idelalisib based on standard criteria [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Flow cytometric measurement of phosphorylation of Akt and S6 within the tumor B cells [ Time Frame: Periodically for 12 months ] [ Designated as safety issue: No ]
  • Flow cytometric measurement of tumoral and peripheral blood T and NK cells [ Time Frame: Periodically for 12 months ] [ Designated as safety issue: No ]
  • Changes in concentration of peripheral blood chemokines and cytokines [ Time Frame: Periodically for 12 months ] [ Designated as safety issue: No ]
  • Changes in liver imaging as assessed by MRI [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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
Idelalisib tables 150 mg administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 years
  • Previously treated low-grade (indolent) B-cell NHL
  • Measurable disease by CT scan, defined as at least 2 lesions that measure > 1.5 cm in a single dimension (one of which is superficial and easily accessible for biopsy)
  • WHO performance status of ≤ 2
  • For men and women of child-bearing potential, willing to use adequate contraception (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study
  • Provide written informed consent

Exclusion Criteria:

  • Pregnant or nursing
  • Significant, ongoing co-morbid conditions which would preclude safe delivery of the study drug
  • History of a transplant with current active graft-versus-host-disease
  • Known active central nervous system involvement of the malignancy
  • Active, serious infection requiring systemic therapy
  • Positive test for HIV antibodies
  • Active hepatitis B or C viral infection
  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 identifier: NCT01306643

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
Principal Investigator: Joshua Brody, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Gilead Sciences Identifier: NCT01306643     History of Changes
Other Study ID Numbers: 101-10 
Study First Received: February 25, 2011
Last Updated: October 14, 2015
Health Authority: United States: Food and Drug Administration

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:
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on December 09, 2016