RECRUITING

A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma (GOLSEEK-4)

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Conditions

Follicular LymphomaSecond Line Follicular LymphomaThird Line Follicular LymphomaRelapsed/refractory follicular lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

Official Title

A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) Vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma

Quick Facts

Study Start:2025-07-28
Study Completion:2030-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06911502

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant has histologically confirmed FL (Grade 1, 2, or 3a) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology confirmation of relapse, is required. Evaluation from fine needle aspirate is not permitted.
  2. * Relapsed or refractory disease:
  3. 1. Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
  4. 2. Refractory FL is defined as best response of SD or PD to the most recent prior therapy.
  5. * Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).
  6. * Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross section imaging by CT, as defined by Lugano classification.
  7. * Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
  8. * Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20 monoclonal antibody (eg, rituximab, obinutuzumab) and an alkylating agent (eg, cyclophosphamide, bendamustine). Prior treatment with radiation therapy does not count as a line of therapy for eligibility.
  9. * Lab parameters:
  10. 1. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L),
  11. 2. PLT count ≥ 75,000 cells/mm3 (75 x 109 /L)
  12. 3. Hb ≥ 7.5 g/dL
  13. * estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m².
  14. * Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0× ULN.
  15. * Serum total bilirubin ≤ 1.5 × ULN (corresponding to mild dysfunction as per National Cancer Institute Organ Dysfunction Working Group \[NCI ODWG\] criteria). In case of documented liver involvement by lymphoma, serum total bilirubin must be ≤ 3.0 × ULN (corresponding to moderate dysfunction as per NCI ODWG criteria). For cases of Gilberts syndrome, serum total bilirubin≤ 5.0 × ULN
  16. * Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA)
  1. * Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL) or any other indolent lymphoma.
  2. * Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL.
  3. * Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly participating in the study based on Investigator's judgment.
  4. * Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment.
  5. * Presence or history of central nervous system (CNS) involvement by lymphoma.
  6. * History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  7. * Deep venous thrombosis/Pulmonary embolism within 1 month prior to enrollment.
  8. * Participants with a history of progressive multifocal leukoencephalopathy.
  9. * Participant has any other subtype of lymphoma.
  10. * Participant has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
  11. * History of another primary malignancy that has not been in remission for ≥ 3 years except for non-invasive malignancies.
  12. * Participants who are refractory to both chemotherapies as well as lenalidomide, defined as:
  13. 1. SD/progressive disease as best response to CHOP and Bendamustine based immunochemotherapy or a response to CHOP and Bendamustine based immunochemotherapy that lasted less than 6 months AND
  14. 2. SD/progressive disease as best response to lenalidomide based regimen or a response to lenalidomide based regimen that lasted less than 6 months.
  15. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
8559073286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0225
Birmingham, Alabama, 35205
United States
Local Institution - 0014
Mobile, Alabama, 36607
United States
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
United States
Local Institution - 0215
Little Rock, Arkansas, 72205
United States
Local Institution - 0072
Duarte, California, 91010
United States
Local Institution - 0119
San Francisco, California, 94143
United States
Local Institution - 0008
Jacksonville, Florida, 32256
United States
Local Institution - 0214
Tampa, Florida, 33606
United States
Local Institution - 0217
Tampa, Florida, 33612
United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
United States
Local Institution - 0245
Newnan, Georgia, 30265
United States
Local Institution - 0240
Arlington Heights, Illinois, 60005
United States
Local Institution - 0243
Waukee, Iowa, 50309
United States
Local Institution - 0216
Westwood, Kansas, 66205
United States
Local Institution - 0218
Lexington, Kentucky, 40536
United States
Local Institution - 0023
Baltimore, Maryland, 21201
United States
Greater Baltimore Medical Center
Towson, Maryland, 21204
United States
Local Institution - 0145
Boston, Massachusetts, 02114
United States
Local Institution - 0244
Boston, Massachusetts, 02215
United States
Local Institution - 0247
Boston, Massachusetts, 02215
United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401-7233
United States
Local Institution - 0144
Providence, Rhode Island, 02903
United States
Local Institution - 0237
Austin, Texas, 78705
United States
Local Institution - 0212
Fort Worth, Texas, 76104
United States
Local Institution - 0230
San Antonio, Texas, 78240
United States
Local Institution - 0236
Tyler, Texas, 75702
United States
Local Institution - 0238
Fairfax, Virginia, 22304
United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, 22408
United States
Local Institution - 0146
Roanoke, Virginia, 24014
United States
Local Institution - 0143
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: Celgene

  • Bristol Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

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 Registration Dates

Study Start Date2025-07-28
Study Completion Date2030-07-31

Study Record Updates

Study Start Date2025-07-28
Study Completion Date2030-07-31

Terms related to this study

Keywords Provided by Researchers

  • Follicular Lymphoma
  • Second Line Follicular Lymphoma
  • Third Line Follicular Lymphoma
  • Relapsed/refractory follicular lymphoma

Additional Relevant MeSH Terms

  • Follicular Lymphoma