Study on the Effectiveness and Safety of Golcadomide with Rituximab for Newly Diagnosed Advanced Follicular Lymphoma

Sponsor: Celgene

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06425302

Provider View

This clinical trial is testing a new treatment combining the drugs golcadomide and rituximab to see if it is effective and safe for patients who have been newly diagnosed with advanced stage Follicular Lymphoma.

Patient Parameters

Program Overview

The goal of this study is to find out if a new combination of drugs, golcadomide and rituximab, can effectively treat patients who have recently been diagnosed with advanced stage Follicular Lymphoma (FL). Researchers are also looking to ensure that this treatment is safe for patients to use.

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.

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