Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Celgene
Study ID
NCT06356129
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Golcadomide — DRUG
    Specified dose on specified days
  • Placebo — 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

Study Details

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

Key Dates

Start date
Jun 19, 2024
Status verified
Feb 2026
Primary completion
Aug 14, 2028
Completion
Nov 20, 2029

Study Design

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

Arms

  • Experimental: Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)
  • Placebo Comparator: Placebo + R-CHOP

Primary Outcome Measure

Progression-free survival (PFS) assessed by the Investigator [ Time Frame: Up to approximately 67 months ]

Locations (46)

FacilityCityStateZIPSite coordinators
Local Institution - 0014MobileAlabama36604-
Local Institution - 0477AnchorageAlaska99508-
Local Institution - 0452PhoenixArizona85054-
Local Institution - 0342San FranciscoCalifornia94143-
Local Institution - 0497Fort MyersFlorida33901-
Local Institution - 0287JacksonvilleFlorida32224-
Local Institution - 0415MargateFlorida33063-
Local Institution - 0045Miami BeachFlorida33140-
Local Institution - 0012PensacolaFlorida32504-
Local Institution - 0502St. PetersburgFlorida33705-
Local Institution - 0414TampaFlorida33612-
Local Institution - 0192West Palm BeachFlorida33401-
Local Institution - 0485WestonFlorida33331-
Local Institution - 0303AtlantaGeorgia30322-
Local Institution - 0515AtlantaGeorgia30303-
Local Institution - 0182ChicagoIllinois60611-
Local Institution - 0048SkokieIllinois60077-
Local Institution - 0461WaukeeIowa50309-
Local Institution - 0031WestwoodKansas66205-
Local Institution - 0436EdgewoodKentucky41017-
Local Institution - 0408Baton RougeLouisiana70809-
Local Institution - 0478Ann ArborMichigan48109-
Local Institution - 0067MinneapolisMinnesota55407-
Local Institution - 0203RochesterMinnesota55905-
Local Institution - 0437Kansas CityMissouri64132-
Local Institution - 0466RenoNevada89511-
Local Institution - 0498East BrunswickNew Jersey08816-
Local Institution - 0480HackensackNew Jersey07601-
Local Institution - 0049MorristownNew Jersey07960-
Local Institution - 0175New BrunswickNew Jersey08901-
Local Institution - 0190BuffaloNew York14263-
Local Institution - 0451East SyracuseNew York13057-
Local Institution - 0176New YorkNew York10029-
Local Institution - 0369New YorkNew York10028-
Local Institution - 0484New YorkNew York10016-
Local Institution - 0174Chapel HillNorth Carolina27599-
Local Institution - 0066MassillonOhio44646-
Local Institution - 0450TulsaOklahoma74146-
Local Institution - 0179PortlandOregon97239-
Local Institution - 0009PittsburghPennsylvania15232-
Local Institution - 0419YorkPennsylvania17403-
Local Institution - 0435Fort Sam HoustonTexas78234-
Local Institution - 0046HoustonTexas77030-
Local Institution - 0424HoustonTexas77030-
Local Institution - 0516HoustonTexas77026-
Local Institution - 0293RichmondVirginia23298-

Find similar trials in Mobile, AL

By research site
Local Institution - 0014· Mobile, ALLocal Institution - 0477· Anchorage, AKLocal Institution - 0452· Phoenix, AZLocal Institution - 0342· San Francisco, CALocal Institution - 0497· Fort Myers, FLLocal Institution - 0287· Jacksonville, FL

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