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

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) - GOLSEEK-1

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080620

Enrollment

850

Registered

2025-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C858- Other specified types of non-Hodgkin lymphoma

Interventions

Intervention1: Golcadomide(BMS-986369/CC-99282) Plus R-CHOP: 1) Drug: Golcadomide, Route of Administration: PO, Intervention Dose: 0.4mg once daily, Dosing Day(s)(21-day cycle): 1-7 2)Drug: Ritu

PO, by mouth

R-CHOP, rituximab, doxorubicin, vincristine, cyclophosphamide, and prednisone

SC, subcutaneous. a: Prednisolone IV products to be sourced locally by sites. Control Intervention1: Placebo Plus R-CHOP: 1) Drug: Placebo Route of Administration: PO Intervention Dose: Once daily Dos

Eligibility

Inclusion criteria

Inclusion criteria: A) · Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated LBCL according to 2022 WHO classification including: 1) DLBCL, NOS (including GCB and ABC types) 2) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements 3) High-grade B-cell lymphoma, NOS 4) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL) 5) EBV plus DLBCL B) · Participant has: 1) IPI score 1 or 2 with LDH more than equal to 1.3 x ULN and/or bulky disease defined as single lesion of more than equal to 7 cm OR IPI more than equal to 3 2) Measurable disease defined by at least 1 FDG-avid lesion for FDG-avid subtype and 1 bi- dimensionally measurable (more than 1.5 cm in longest diameter) disease by CT or MRI, as defined by the Lugano classification. 3) Participants must have Ann Arbor Stage II-IV disease

Exclusion criteria

Exclusion criteria: 1) · Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. 2) · Participant has any other subtype of lymphoma. Cases of PMBCL, primary cutaneous DLBCL-leg type, Grade 3b FL, FL transformed to a-BCL, ALK-positive large B-cell lymphoma, PEL, Burkitt lymphoma are excluded. 3) · Participant has documented or suspected CNS involvement by lymphoma.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the investigator.Timepoint: At baseline, 24 Months and until Progression free survival up to 5 years or study achieves endpoints	—

Secondary

Measure	Time frame
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOPTimepoint: 1) OS defined as the time from randomization to death from any cause 2) Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit.;To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to EFS as assessed by the InvestigatorTimepoint: 1) Death, disease progression or relapse, initiation of subsequent systemic anti-lymphoma therapy,biopsy-proven disease after end of treatment 2)Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit.;evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to CMR as assessed by the IRACTimepoint: 1) Complete metabolic response per IRAC defined as participant achieving CMR at EOT as assessed by IRAC based on the Lugano response criteria 2) Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit.;To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to MRD negativity at EOT.Timepoint: 1) MRD negativity defined as participant having undetectable ctDNA levels at EOT. 2) Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit.	—

Measure

Time frame

To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOPTimepoint: 1) OS defined as the time from randomization to death from any cause 2) Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit.;To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to EFS as assessed by the InvestigatorTimepoint: 1) Death, disease progression or relapse, initiation of subsequent systemic anti-lymphoma therapy,biopsy-proven disease after end of treatment 2)Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit.;evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to CMR as assessed by the IRACTimepoint: 1) Complete metabolic response per IRAC defined as participant achieving CMR at EOT as assessed by IRAC based on the Lugano response criteria 2) Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit.;To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to MRD negativity at EOT.Timepoint: 1) MRD negativity defined as participant having undetectable ctDNA levels at EOT. 2) Baseline cycle 4 day 1 & cycle6 day 8, End of treatment visit.

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Netherlands, Poland, Republic of Korea, Romania, Spain, Switzerland, Taiwan, United Kingdom, United States of America

Contacts

Public ContactShilpi Sinha

Bristol Myers Squibb India Pvt. Ltd.

Shilpi.Sinha@bms.com02266288600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026