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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Celgene
Study ID
NCT06425302
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Lymphoma, Follicular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golcadomide — DRUG
    Specified dose on specified days
  • Rituximab — DRUG
    Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days
  • Doxorubicin — DRUG
    Specified dose on specified days
  • Vincristine — DRUG
    Specified dose on specified days
  • Prednisone — DRUG
    Specified dose on specified days
  • Bendamustine — DRUG
    Specified dose on specified days

Study Details

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).

Key Dates

Start date
Aug 30, 2024
Status verified
Jan 2026
Primary completion
Nov 23, 2026
Completion
Nov 27, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab + Chemotherapy
    R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
  • Experimental: Golcadomide Dose 1 + Rituximab
  • Experimental: Golcadomide Dose 2 + Rituximab

Primary Outcome Measure

Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014 [ Time Frame: Up to approximately 12 months from participant randomization ]

Locations (18)

FacilityCityStateZIPSite coordinators
Local Institution - 0152BirminghamAlabama35294-3300-
Local Institution - 0055AnchorageAlaska99508-
Local Institution - 0180PhoenixArizona85054-
Local Institution - 0190TucsonArizona85711-
Local Institution - 0035San FranciscoCalifornia94143-
Local Institution - 0022Washington D.C.District of Columbia20007-
Local Institution - 0209Fort MyersFlorida33901-
Local Institution - 0005JacksonvilleFlorida32224-
Local Institution - 0210St. PetersburgFlorida33705-
Local Institution - 0026TampaFlorida33606-
Local Institution - 0208West Palm BeachFlorida33401-
Local Institution - 0019WestwoodKansas66205-
Local Institution - 0031RochesterMinnesota55905-
Local Institution - 0111HendersonNevada89074-
Local Institution - 0183HackensackNew Jersey07601-
Local Institution - 0052Salt Lake CityUtah84106-
Local Institution - 0201NorfolkVirginia23502-
Local Institution - 0202SeattleWashington98109-

Find similar trials in Birmingham, AL

By research site
Local Institution - 0152· Birmingham, ALLocal Institution - 0055· Anchorage, AKLocal Institution - 0180· Phoenix, AZLocal Institution - 0190· Tucson, AZLocal Institution - 0035· San Francisco, CALocal Institution - 0022· Washington D.C., DC

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