Suspended

GOLSEEK-1Golcadomide Plus R-CHOP for High-risk Large B-cell Lymphoma

Study Aim

This study aims to evaluate the effectiveness of Golcadomide combined with R-CHOP in improving progression-free survival in adults with high-risk large B-cell lymphoma.

What is being tested

Golcadomide

+ Rituximab

+ Cyclophosphamide

Drug

Who is being recruted

Hemic and Lymphatic Diseases+5

+ Immune System Diseases

+ Immunoproliferative Disorders

From 18 to 80 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: June 2024

See protocol details

Summary

Principal SponsorCelgene

Last updated: February 13, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 19, 2024

Actual date on which the first participant was enrolled.

This study focuses on finding out how effective and safe the drug golcadomide is when used alongside a standard chemotherapy treatment known as R-CHOP, compared to using a placebo with the same chemotherapy. Participants in this study have a type of cancer called high-risk large B-cell lymphoma and have not received any treatment for it before. The main goal is to see if adding golcadomide to the treatment plan can improve outcomes for these patients, possibly offering a better treatment option in the future. Participants in this study are divided into two groups. One group receives golcadomide along with the standard R-CHOP chemotherapy, while the other group receives a placebo with the same chemotherapy. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the actual drug or the placebo. This helps ensure that the results are unbiased. The study aims to measure both how well the treatment works and any side effects that might occur, providing valuable information on the potential benefits and risks of using golcadomide in treating this type of lymphoma.

Official TitleA 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)

NCT06356129

Principal SponsorCelgene

Last updated: February 13, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

850 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type

Criteria

4 inclusion criteria required to participate

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: Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types], High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas), High-grade B-cell lymphoma, not otherwise specified, T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL), Epstein-Barr virus + DLBCL

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

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

Must have Ann Arbor Stage II-IV disease

4 exclusion criteria prevent from participating

Other protocol-defined Inclusion/Exclusion criteria apply

Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), 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

Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 325 locations

Suspended

Local Institution - 0164

Viña del Mar, ChileOpen Local Institution - 0164 in Google Maps

Suspended

Local Institution - 0014

Mobile, United States

Suspended

Local Institution - 0477

Anchorage, United States

Suspended

Local Institution - 0452

Phoenix, United States

Suspended325 Study Centers