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Completed

NCT Number: NCT01306643

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

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.

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Key information

Conditions

Indolent Non-Hodgkin's Lymphoma Chronic Disease Disease Attributes Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Marginal Zone Lymphoma Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford Cancer Center, Palo Alto, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

idelalisib

Drug

Tablet(s) administered orally twice daily

Other names: GS-1101, CAL-101, Zydelig®

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2011
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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