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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

NCT06425302

Active Not RecruitingPhase 2

Sponsor: Celgene

Conditions: Lymphoma, Follicular

Interventions: Golcadomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine

Countries: United States, Australia, Brazil, Canada, Chile, France, Germany, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

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).

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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (56)

Birmingham, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
San Francisco, California, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Westwood, Kansas, United States
Rochester, Minnesota, United States
Henderson, Nevada, United States
Hackensack, New Jersey, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Liverpool, New South Wales, Australia
South Brisbane, Queensland, Australia
Traralgon, Victoria, Australia
Porto Alegre, Rio Grande do Sul, Brazil
Rio de Janeiro, Brazil
São Paulo, Brazil
São Paulo, Brazil
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Santiago, Santiago Metropolitan, Chile
Santiago, Santiago Metropolitan, Chile
Saint-Cloud, Hauts-de-Seine, France
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