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

Running, not enrolling · Phase 2

Conditions studied: Lymphoma, Follicular

In brief

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).

Key facts

Study ID: NCT06425302
Run by: Celgene
People needed: 95
Starts: 2024-08-30
Expected to finish: 2028-11-27
Last updated by the study team: 2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
iii) Splenomegaly with inferior margin below the umbilical line.
iv) Any one of the following cytopenia due to lymphoma:.
A. Platelets <100,000 cells/mm3 (100 x 109/L).
B. Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L).
C. Hemoglobin < 10g/dL (6.25 mmol/L).
v) Pleural or peritoneal serous effusion (irrespective of cell content).
vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).

You may not qualify if…

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.
Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

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
Local Institution - 0208 — West Palm Beach, Florida, United States
Local Institution - 0019 — Westwood, Kansas, United States
Local Institution - 0031 — Rochester, Minnesota, United States
Local Institution - 0111 — Henderson, Nevada, United States
Local Institution - 0183 — Hackensack, New Jersey, United States
Local Institution - 0052 — Salt Lake City, Utah, United States
Local Institution - 0201 — Norfolk, Virginia, United States
Local Institution - 0202 — Seattle, Washington, United States
Local Institution - 0046 — Liverpool, New South Wales, Australia
Local Institution - 0070 — South Brisbane, Queensland, Australia
Local Institution - 0181 — Traralgon, Victoria, Australia
Local Institution - 0061 — Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0060 — Rio de Janeiro, Brazil
Local Institution - 0058 — São Paulo, Brazil
Local Institution - 0056 — São Paulo, Brazil
Local Institution - 0152 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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