A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (GOLSEEK-2)

July 30, 2026 updated by: Celgene

A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Local Institution - 0046
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Local Institution - 0070
    • Victoria
      • Traralgon, Victoria, Australia, 3844
        • Local Institution - 0181
  • Brazil
      • Rio de Janeiro, Brazil, 22250-905
        • Local Institution - 0060
      • São Paulo, Brazil, 05652-900
        • Local Institution - 0056
      • São Paulo, Brazil, 04543-000
        • Local Institution - 0058
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Local Institution - 0061
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0064
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Local Institution - 0205
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 0049
      • Santiago, Santiago Metropolitan, Chile, 7580206
        • Local Institution - 0050
  • France
      • Paris, France, 75010
        • Local Institution - 0118
    • Hauts-de-Seine
      • Saint-Cloud, Hauts-de-Seine, France, 92210
        • Local Institution - 0101
    • Nord
      • Lille, Nord, France, 59000
        • Local Institution - 0103
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Local Institution - 0121
  • Germany
      • Dresden, Germany, 01307
        • Local Institution - 0189
    • Bavaria
      • Regensburg, Bavaria, Germany, 93049
        • Local Institution - 0197
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Local Institution - 0188
  • Italy
      • Bologna, Italy, 40138
        • Local Institution - 0076
      • Naples, Italy, 80131
        • Local Institution - 0075
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Local Institution - 0198
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Local Institution - 0179
  • Poland
    • Greater Poland Voivodeship
      • Skórzewo, Greater Poland Voivodeship, Poland, 60-185
        • Local Institution - 0187
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Local Institution - 0186
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-748
        • Local Institution - 0185
  • South Korea
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, South Korea, 49241
        • Local Institution - 0100
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Local Institution - 0085
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Local Institution - 0086
  • Spain
      • Madrid, Spain, 28040
        • Local Institution - 0191
    • Balears [Baleares]
      • Palma, Balears [Baleares], Spain, 07120
        • Local Institution - 0196
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46017
        • Local Institution - 0192
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Local Institution - 0094
      • Kaohsiung City, Taiwan, 83301
        • Local Institution - 0092
      • Taipei, Taiwan, 10002
        • Local Institution - 0123
  • United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • Local Institution - 0105
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 0YD
        • Local Institution - 0175
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3NG
        • Local Institution - 0112
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • Local Institution - 0115
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • Local Institution - 0152
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Local Institution - 0055
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Local Institution - 0180
      • Tucson, Arizona, United States, 85711
        • Local Institution - 0190
    • California
      • San Francisco, California, United States, 94143
        • Local Institution - 0035
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Local Institution - 0022
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Local Institution - 0209
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 0005
      • St. Petersburg, Florida, United States, 33705
        • Local Institution - 0210
      • Tampa, Florida, United States, 33606
        • Local Institution - 0026
      • West Palm Beach, Florida, United States, 33401
        • Local Institution - 0208
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Local Institution - 0019
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 0031
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Local Institution - 0111
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0183
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Local Institution - 0052
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Local Institution - 0201
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 0202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
  • Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
  • Stage II to IV disease.

  • Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.

    i) Bulky disease defined as:.

A. A nodal or extra nodal (except spleen) mass > 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than >3 cm).

ii) Presence of at least one of the following B symptoms:.

A. Fever (>38°C) of unclear etiology.

B. Night sweats.

C. Weight loss greater than 10% within the prior 6 months.

iii) Splenomegaly with inferior margin below the umbilical line.

iv) Any one of the following cytopenia due to lymphoma:.

A. Platelets <100,000 cells/mm3 (100 x 109/L).

B. Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L).

C. Hemoglobin < 10g/dL (6.25 mmol/L).

v) Pleural or peritoneal serous effusion (irrespective of cell content).

vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).

Exclusion Criteria

  • Clinical evidence of transformed lymphoma by investigator assessment.
  • Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
  • Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab + Chemotherapy
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Drug: Rituximab
Specified dose on specified days
Other Names:
  • Mabthera
Drug: Prednisone
Specified dose on specified days
Drug: Cyclophosphamide
Specified dose on specified days
Other Names:
  • Endoxan
Drug: Doxorubicin
Specified dose on specified days
Other Names:
  • Caelyx
  • pegylated liposomal doxorubicin
  • PLD
Drug: Bendamustine
Specified dose on specified days
Drug: Vincristine
Specified dose on specified days
Experimental: Golcadomide Dose 1 + Rituximab
Drug: Rituximab
Specified dose on specified days
Other Names:
  • Mabthera
Drug: Golcadomide
Specified dose on specified days
Other Names:
  • BMS-986369
  • CC-99282
Experimental: Golcadomide Dose 2 + Rituximab
Drug: Rituximab
Specified dose on specified days
Other Names:
  • Mabthera
Drug: Golcadomide
Specified dose on specified days
Other Names:
  • BMS-986369
  • CC-99282

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
Time Frame: Up to approximately 12 months from participant randomization
Golcadomide + Rituximab arms only
Up to approximately 12 months from participant randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0
Time Frame: Up to 28 days after last dose
Up to 28 days after last dose
Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0
Time Frame: Up to 28 days after last dose
Up to 28 days after last dose
Best Overall Response (OR)
Time Frame: Up to approximately 12 months from participant randomization
Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014
Up to approximately 12 months from participant randomization
Duration of Response (DoR)
Time Frame: Up to approximately 3 years after randomization of the last participant
Defined as time from first confirmed response (Complete Response (CR) or Partial Response (PR)) to disease progression, start of new anti-lymphoma therapy, or death
Up to approximately 3 years after randomization of the last participant
Complete Response at 30 months (CR30)
Time Frame: At approximately 30 months from randomization
Defined as achieving CR based on Lugano criteria at 30 months from randomization
At approximately 30 months from randomization
Complete Metabolic Response at 6 months from the randomization (CMR6)
Time Frame: At approximately 6 months from randomization
Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization
At approximately 6 months from randomization
Complete Metabolic Response at 12 months from the randomization (CMR12)
Time Frame: At approximately 12 months from randomization
Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization
At approximately 12 months from randomization
Progression Free Survival (PFS)
Time Frame: Up to approximately 3 years from randomization of last participant
Defined as time from date of randomization to first occurrence of disease progression or death from any cause
Up to approximately 3 years from randomization of last participant
Overall Survival (OS)
Time Frame: Up to approximately 3 years from randomization of last participant
Defined as time from date of randomization to death from any cause
Up to approximately 3 years from randomization of last participant
Number of participants who achieve CMR as assessed by Lugano criteria 2014
Time Frame: Up to approximately 6 months from randomization
Rituximab + Chemotherapy arm only
Up to approximately 6 months from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Actual)

June 19, 2026

Study Completion (Estimated)

November 27, 2028

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA073-1022
  • U1111-1303-4594 (Other Identifier: WHO)
  • 2024-511304-16 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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