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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 (GOLSEEK-2)

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Celgene

Status and phase

Begins enrollment this month
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 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)

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

Trial contacts and locations

65

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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