Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

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).

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)

Keywords

Large B-cell Lymphoma, Lymphoma, Large B-Cell, Lymphoma, BMS-986369, CC-99282, DLBCL, B-Cell Lymphoma, Prednisone, Cyclophosphamide, Rituximab, Doxorubicin, Vincristine, Golcadomide, Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)

Eligibility

You can join if…

Open to people ages 18-80

  • Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:

i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types]

ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements

iii) High-grade B-cell lymphoma, not otherwise specified

iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)

v) Epstein-Barr virus + DLBCL

  • International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) ≥ 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
  • Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
  • Must have Ann Arbor Stage II-IV disease.

You CAN'T join if...

  • Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  • Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, FL transformed to a-BCL, Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
  • Documented or suspected central nervous system (CNS) involvement by lymphoma.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

  • Local Institution - 0342
    San Francisco California 94143 United States
  • Local Institution - 0466
    Reno Nevada 89511 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06356129
Phase
Phase 3 Lymphoma Research Study
Study Type
Interventional
Participants
Expecting 850 study participants
Last Updated