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

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

  • Lymphoma, Follicular

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) < 1,000 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.

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

Alaska Oncology and Hematology
Anchorage, Alaska 99508
Contact:
Steven Liu, Site 0055
907-257-9851

Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona 85054
Contact:
Talal Hilal, Site 0180
480-301-8000

Arizona Oncology Associates, PC - HOPE
Tucson, Arizona 85711
Contact:
Laurie Chen, Site 0190
000-000-0000

UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California 94143
Contact:
Carrie Ho, Site 0035
415-353-9327

Georgetown University Medical Center
Washington, District of Columbia 20007
Contact:
Joseph Roswarski, Site 0022
202-444-2223

Florida Cancer Specialists - South
Fort Myers, Florida 33901
Contact:
Blessy Jacob, Site 0209
000-000-0000

Mayo Clinic in Florida
Jacksonville, Florida 32224
Contact:
Muhamad Alhaj Moustafa, Site 0005
904-953-2000

Florida Cancer Specialists - North
Saint Petersburg, Florida 33705
Contact:
Jennifer Cultrera, Site 0210
727-216-1143

Tampa General Hospital
Tampa, Florida 33606
Contact:
Daniel Kerr, Site 0026
813-844-7585

Florida Cancer Specialists - East
West Palm Beach, Florida 33401
Contact:
Eric Harris, Site 0208
561-366-4100

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

Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
Contact:
J. C. Villasboas, Site 0031
507-284-4392

Comprehensive Cancer Centers Of Nevada
Henderson, Nevada 89074
Contact:
Edwin Kingsley, Site 0111
702-952-1251

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Lori Leslie, Site 0183
201-341-5859

Utah Cancer Specialists
Salt Lake City, Utah 84106
Contact:
Stephan Kendall, Site 0052
801-462-1053

Virginia Oncology Associates
Norfolk, Virginia 23502
Contact:
Celeste Ann Bremer, Site 0201
757-466-8683

Fred Hutchinson Cancer Center
Seattle, Washington 98109
Contact:
Christina Poh, Site 0202
206-606-2384

More Details

NCT ID
NCT06425302
Status
Recruiting
Sponsor
Celgene

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center