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NCT Number: NCT06911502

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 Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Westmead Hospital, Westmead, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) 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.
  • Relapsed or refractory disease: i) Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.

ii) Refractory FL is defined as best response of SD or PD or a response that lasted less than 6 months to the most recent prior therapy.

  • Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).
  • 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.
  • Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
  • 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.
  • Lab parameters:

i) Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L), ii) PLT count ≥ 75,000 cells/mm3 (75 x 109 /L) iii) Hb ≥ 7.5 g/dL

  • estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m².
  • 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.
  • 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.
  • Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA).

Exclusion criteria

  • Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL), including history of prior large B-cell lymphomas (LBCL), or any other indolent lymphoma.
  • Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL.
  • 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.
  • Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment.
  • Presence or history of central nervous system (CNS) involvement by lymphoma.
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  • Deep venous thrombosis/Pulmonary embolism within 1 month prior to enrollment.
  • Participants with a history of progressive multifocal leukoencephalopathy.
  • Participant has any other subtype of lymphoma.
  • Participant has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
  • History of another primary malignancy that has not been in remission for ≥ 3 years except for non-invasive malignancies.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

golcadomide

Drug

Specified dose on specified days

Other names: CC-99282, BMS-986369

Rituximab

Drug

Specified dose on specified days

Lenalidomide

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/prednisolone

Drug

Specified dose on specified days

Bendamustine

Drug

Specified dose on specified days

Primary outcomes

  1. Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)

    Time frame: Up to approximately 32 Months

Secondary outcomes

  1. Overall response rate (ORR) assessed by IRAC

    Time frame: Up to approximately 32 Months

  2. Overall survival (OS)

    Time frame: Up to approximately 83 Months

  3. PFS as assessed by investigator

    Time frame: Up to approximately 32 Months

  4. ORR as assessed by investigator

    Time frame: Up to approximately 32 Months

  5. Number of participants who achieve complete metabolic response (CMR)

    Time frame: Up to approximately 32 Months

  6. Duration of Response (DoR)

    Time frame: Up to approximately 32 Months

  7. Event free survival (EFS)

    Time frame: Up to approximately 32 Months

  8. Time to next anti-lymphoma treatment (TTNT)

    Time frame: Up to approximately 32 Months

  9. PFS on next anti-lymphoma treatment (PFS2)

    Time frame: Up to approximately 32 Months

  10. 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 32 Months

  11. Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Non- Hodgkin Lymphoma- Low Grade- 20 items (EORTC QLQNHL- LG20) Questionnaire

    Time frame: Up to approximately 32 Months

  12. Minimal residual disease (MRD) negativity

    Time frame: Up to approximately 32 Months

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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 Who Have Received at Least 1 Prior Line of Systemic Therapy

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Apr 4, 2025
Registry last updated
May 20, 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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