A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (GOLSEEK-2)

Celgene

Status and phase: Enrolling; Phase 2

Conditions: Lymphoma, Follicular

Treatments: Drug: Golcadomide; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Drug: Bendamustine; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06425302

2024-511304-16 (Other Identifier)

CA073-1022

U1111-1303-4594 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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) < 1,500 cells/mm3 (1.5 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Rituximab + Chemotherapy

Experimental group

Description:

R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine

Treatment:

Drug: Bendamustine

Drug: Rituximab

Drug: Prednisone

Drug: Vincristine

Drug: Cyclophosphamide

Drug: Doxorubicin

Golcadomide Dose 1 + Rituximab

Experimental group

Treatment:

Drug: Rituximab

Drug: Golcadomide

Golcadomide Dose 2 + Rituximab

Experimental group

Treatment:

Drug: Rituximab

Drug: Golcadomide