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A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

NCT06425302•Celgene

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
•Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
•Stage II to IV disease.
•Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.
•i) Bulky disease defined as:.
•A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm).
•ii) Presence of at least one of the following B symptoms:.
•A. Fever (\>38°C) of unclear etiology.
•B. Night sweats.
•C. Weight loss greater than 10% within the prior 6 months.
+7 more criteria

Exclusion Criteria

•Clinical evidence of transformed lymphoma by investigator assessment.
•Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
•Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.

Locations (56)

Local Institution - 0152

Birmingham, Alabama, United States

Local Institution - 0055

Anchorage, Alaska, United States

Local Institution - 0180

Phoenix, Arizona, United States

Local Institution - 0190

Tucson, Arizona, United States

Local Institution - 0035

San Francisco, California, United States

Local Institution - 0022

Washington D.C., District of Columbia, United States

Local Institution - 0209

Fort Myers, Florida, United States

Local Institution - 0005

Jacksonville, Florida, United States

Local Institution - 0210

St. Petersburg, Florida, United States

Local Institution - 0026

Tampa, Florida, United States

Key Dates

Start Date

August 30, 2024

Primary Completion Date

November 23, 2026

Completion Date

November 27, 2028

Last Updated

January 8, 2026

Enrollment

ESTIMATED participants

Conditions

Lymphoma, Follicular

Interventions

Golcadomide

DRUG

Rituximab

DRUG

Cyclophosphamide

DRUG

Doxorubicin

DRUG

Vincristine

DRUG

Prednisone

DRUG

Bendamustine

DRUG

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B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma

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Lymphoma, FollicularLymphoma, Mantle-Cell+4 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: January 8, 2026Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

Inclusion Criteria

Exclusion Criteria

Long-term Follow up Local Registry Study of Kymriah in South Korea

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