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COMPLETEDPHASE2

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas

A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents

NCT01282424•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Karnofsky performance status of ≥ 60 (Eastern Cooperative Oncology Group \[ECOG\] performance score of 0, 1, or 2)
•Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
•* Follicular lymphoma (FL)
•* Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \< 5 x 10\^9/L at the time of diagnosis and on baseline laboratory assessment performed within 4 weeks prior to the start of study drug administration
•* Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms Macroglobulinemia (WM)
•* Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)
•Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL
•Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
•Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL
•Lymphoma that is refractory to rituximab and to an alkylating agent
+3 more criteria

Exclusion Criteria

•Central nervous system or leptomeningeal lymphoma
•Known histological transformation from iNHL to diffuse large B-cell lymphoma
•History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years
•Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment
•Pregnancy or breastfeeding
•Ongoing alcohol or drug addiction
•Known history of drug-induced liver injury, chronic active hepatitis B infection, chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension
•History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
•Ongoing immunosuppressive therapy, including systemic corticosteroids. Participant may be using topical or inhaled corticosteroids.
•Prior therapy with idelalisib
+3 more criteria

Locations (41)

St. Jude Medical Center

Fullerton, California, United States

Pacific Shores Medical Group

Long Beach, California, United States

UCLA

Los Angeles, California, United States

Central Coast Medical Oncology

Santa Maria, California, United States

Stanford Cancer Center

Stanford, California, United States

Collaborative Research Group, LLC

Boynton Beach, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Northwestern University Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Washington University School of Medicine

St Louis, Missouri, United States

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, United States

Key Dates

Start Date

March 18, 2011

Primary Completion Date

May 2, 2018

Completion Date

May 16, 2018

Last Updated

July 11, 2019

Enrollment

125

ACTUAL participants

Conditions

Follicular LymphomaSmall Lymphocytic LymphomaLymphoplasmacytic LymphomaMarginal Zone Lymphoma

Interventions

Idelalisib

DRUG

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT06337318

Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features

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RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

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B-cell MalignancyMarginal Zone Lymphoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas

Inclusion Criteria

Exclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

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