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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rituximab + Chemotherapy 		R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
  • Drug: Rituximab
    Specified dose on specified days
    Other names:
    • Mabthera
  • Drug: Cyclophosphamide
    Specified dose on specified days
    Other names:
    • Endoxan
  • Drug: Doxorubicin
    Specified dose on specified days
    Other names:
    • Caelyx
    • pegylated liposomal doxorubicin
    • PLD
  • Drug: Vincristine
    Specified dose on specified days
  • Drug: Prednisone
    Specified dose on specified days
  • Drug: Bendamustine
    Specified dose on specified days
Experimental
Golcadomide Dose 1 + Rituximab
  • Drug: Golcadomide
    Specified dose on specified days
    Other names:
    • CC-99282
    • BMS-986369
  • Drug: Rituximab
    Specified dose on specified days
    Other names:
    • Mabthera
Experimental
Golcadomide Dose 2 + Rituximab
  • Drug: Golcadomide
    Specified dose on specified days
    Other names:
    • CC-99282
    • BMS-986369
  • Drug: Rituximab
    Specified dose on specified days
    Other names:
    • Mabthera

Recruiting Locations

The University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
Contact:
Marc Hoffmann, Site 0019
913-574-2650

More Details

Status
Recruiting
Sponsor
Celgene

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.