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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)

ConditionFollicular Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelgene

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Golcadomide

    Drug

    Specified dose on specified days

  • 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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Golcadomide + RituximabExperimental treatment 2 interventions
Group B: Rituximab + Lenalidomide/ChemotherapyActive comparator 7 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celgene

Lead sponsor

Source ClinicalTrials.gov
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