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NCT Number: NCT06356129

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0113, Buenos Aires, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 (HGBL-MYC/BCL2 double-hit lymphomas)

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.

Exclusion criteria

  • 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, 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

golcadomide

Drug

Specified dose on specified days

Other names: BMS-986369, CC-99282

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

Primary outcomes

  1. Progression-free survival (PFS) assessed by the Investigator

    Time frame: Approximately 24 months after the last participant's first treatment

Secondary outcomes

  1. PFS assessed by the Investigator

    Time frame: Approximately 24 months after the last participant's first treatment

  2. Overall survival (OS)

    Time frame: Up to approximately 67 months

  3. Event-free survival (EFS)

    Time frame: Approximately 24 months after the last participant's first treatment

  4. Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC)

    Time frame: Up to approximately 18 weeks

  5. Minimal residual disease (MRD) negativity rate

    Time frame: Up to approximately 18 weeks

  6. Progression-free survival (PFS) assessed by the IRAC

    Time frame: Approximately 24 months after the last participant's first treatment

  7. Objective response (OR) assessed by the Investigator

    Time frame: Up to approximately 18 weeks

  8. Complete metabolic response (CMR) assessed by the Investigator

    Time frame: Up to approximately 18 weeks

  9. PFS24 assessed by the Investigator 24 months after randomization

    Time frame: Up to 24 months

  10. Duration of response (DoR)

    Time frame: Up to approximately 67 months

  11. Second progression-free survival (PFS2) assessed by the Investigator

    Time frame: Up to approximately 67 months

  12. Relative dose intensity (%)

    Time frame: Up to 18 weeks

  13. Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire

    Time frame: Up to approximately 67 months

  14. Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire

    Time frame: Up to approximately 67 months

  15. Mean change from baseline in the EORTC QLQ-C30

    Time frame: Up to approximately 67 months

  16. Mean change from baseline in the FACT-LymS

    Time frame: Up to approximately 67 months

  17. Number of participants with Adverse Events (AEs)

    Time frame: Up to approximately 22 weeks

  18. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to approximately 22 weeks

  19. Number of participants with laboratory abnormalities

    Time frame: Up to approximately 22 weeks

  20. Number of participants with vital sign abnormalities

    Time frame: Up to approximately 22 weeks

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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)

Acronym: GOLSEEK-1

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Apr 10, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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