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)

NCT06911502 — Phase 3, Recruiting, 400 participants, Celgene

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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

RegistryNCT06911502
StatusRecruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment400 (Estimated)
SponsorCelgene (Industry)
ConditionsFollicular Lymphoma
InterventionsGolcadomide, Rituximab, Lenalidomide, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone, Bendamustine (Drug)
Datesstart 2025-07-28, primary completion 2028-04-24 (estimated), completion 2030-07-31 (estimated), first posted 2025-04-04, last updated 2026-05-20
Locations160 sites in United States, Australia, Brazil, Canada, Chile, China, Finland, France and 13 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Follicular Lymphoma All trials of Golcadomide All trials of Rituximab

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Golcadomide + RituximabExperimentalDrug: Golcadomide; Drug: Rituximab
Rituximab + Lenalidomide/ChemotherapyActive comparatorDrug: Rituximab; Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone; Drug: BendamustineRituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
  • Golcadomide (Drug), also known as CC-99282, BMS-986369: 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

+Outcome measures

Primary outcomes

  • Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC) [Up to approximately 32 Months]

Secondary outcomes

  • Overall response rate (ORR) assessed by IRAC [Up to approximately 32 Months]
  • Overall survival (OS) [Up to approximately 83 Months]
  • PFS as assessed by investigator [Up to approximately 32 Months]
  • ORR as assessed by investigator [Up to approximately 32 Months]
  • Number of participants who achieve complete metabolic response (CMR) [Up to approximately 32 Months]
  • Duration of Response (DoR) [Up to approximately 32 Months]
  • Event free survival (EFS) [Up to approximately 32 Months]
  • Time to next anti-lymphoma treatment (TTNT) [Up to approximately 32 Months]
  • PFS on next anti-lymphoma treatment (PFS2) [Up to approximately 32 Months]
  • 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 [Up to approximately 32 Months]
  • 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 [Up to approximately 32 Months]
  • Minimal residual disease (MRD) negativity [Up to approximately 32 Months]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (160)

FacilityCityCountryStatus
Local Institution - 0225Birmingham, AlabamaUnited StatesNot yet recruiting
Infirmary Cancer CareMobile, AlabamaUnited StatesRecruiting
Alaska Oncology and HematologyAnchorage, AlaskaUnited StatesRecruiting
Local Institution - 0215Little Rock, ArkansasUnited StatesNot yet recruiting
City of Hope Comprehensive Cancer CenterDuarte, CaliforniaUnited StatesRecruiting
UCSF Helen Diller Medical Center at Parnassus HeightsSan Francisco, CaliforniaUnited StatesRecruiting
Local Institution - 0008Jacksonville, FloridaUnited StatesNot yet recruiting
Local Institution - 0214Tampa, FloridaUnited StatesNot yet recruiting
Local Institution - 0217Tampa, FloridaUnited StatesNot yet recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalMarietta, GeorgiaUnited StatesRecruiting
Southeastern Regional Medical CenterNewnan, GeorgiaUnited StatesRecruiting
Local Institution - 0240Arlington Heights, IllinoisUnited StatesNot yet recruiting
Local Institution - 0253Iowa City, IowaUnited StatesNot yet recruiting
Local Institution - 0243Waukee, IowaUnited StatesNot yet recruiting
Local Institution - 0216Westwood, KansasUnited StatesNot yet recruiting
Local Institution - 0218Lexington, KentuckyUnited StatesNot yet recruiting
Local Institution - 0023Baltimore, MarylandUnited StatesNot yet recruiting
Greater Baltimore Medical CenterTowson, MarylandUnited StatesRecruiting
Local Institution - 0145Boston, MassachusettsUnited StatesNot yet recruiting
Local Institution - 0244Boston, MassachusettsUnited StatesNot yet recruiting
Local Institution - 0247Boston, MassachusettsUnited StatesNot yet recruiting
Hattiesburg Clinic Hematology/OncologyHattiesburg, MississippiUnited StatesRecruiting
Local Institution - 0144Providence, Rhode IslandUnited StatesNot yet recruiting
Texas Oncology - Central/South TexasAustin, TexasUnited StatesRecruiting
Local Institution - 0212Fort Worth, TexasUnited StatesNot yet recruiting
Local Institution - 0230San Antonio, TexasUnited StatesNot yet recruiting
Texas Oncology - Northeast TexasTyler, TexasUnited StatesRecruiting
Local Institution - 0238Fairfax, VirginiaUnited StatesNot yet recruiting
Hematology Oncology Associates of FredericksburgFredericksburg, VirginiaUnited StatesRecruiting
Blue Ridge Cancer CareRoanoke, VirginiaUnited StatesRecruiting
Local Institution - 0143Vancouver, WashingtonUnited StatesNot yet recruiting
Westmead HospitalWestmead, New South WalesAustraliaRecruiting
Local Institution - 0132Adelaide, South AustraliaAustraliaNot yet recruiting
Local Institution - 0131Hobart, TasmaniaAustraliaNot yet recruiting
Local Institution - 0128Heidelberg, VictoriaAustraliaNot yet recruiting
Cabrini Hospital - MalvernMalvern, VictoriaAustraliaRecruiting
Local Institution - 0127Perth, Western AustraliaAustraliaNot yet recruiting
Local Institution - 0224Perth, Western AustraliaAustraliaWithdrawn
Local Institution - 0159Vitória, Espírito SantoBrazilNot yet recruiting
Local Institution - 0088Niterói, Rio de JaneiroBrazilNot yet recruiting
Local Institution - 0087Porto Alegre, Rio Grande do SulBrazilNot yet recruiting
Local Institution - 0079São Paulo, São PauloBrazilNot yet recruiting
Local Institution - 0089Rio de JaneiroBrazilNot yet recruiting
Local Institution - 0066São PauloBrazilNot yet recruiting
Local Institution - 0092São PauloBrazilNot yet recruiting
Local Institution - 0200Victoria, British ColumbiaCanadaNot yet recruiting
Princess Margaret Cancer CentreToronto, OntarioCanadaRecruiting
Local Institution - 0250Québec, QuebecCanadaNot yet recruiting
Local Institution - 0192Sherbrooke, QuebecCanadaNot yet recruiting
Local Institution - 0226Sherbrooke, QuebecCanadaWithdrawn
Local Institution - 0154Santiago, Santiago MetropolitanChileNot yet recruiting
Local Institution - 0155Santiago, Santiago MetropolitanChileNot yet recruiting
Local Institution - 0153Santiago, Santiago MetropolitanChileNot yet recruiting
Local Institution - 0246Beijing, Beijing MunicipalityChinaNot yet recruiting
Beijing Cancer hospitalBeijing, Beijing MunicipalityChinaRecruiting
Local Institution - 0172Fuzhou Fujian, FujianChinaNot yet recruiting
Sun Yat-sen University Cancer CenterGuangzhou, GuangdongChinaRecruiting
Local Institution - 0241Harbin, HeilongjiangChinaNot yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhan, HubeiChinaRecruiting
Local Institution - 0175Changsha, HunanChinaNot yet recruiting
Inner Mongolia Cancer HospitalHohhot, Inner MongoliaChinaRecruiting
Local Institution - 0233Suzhou, JiangsuChinaNot yet recruiting
Local Institution - 0178Nanchang, JiangxiChinaNot yet recruiting
Local Institution - 0239Changchun, JilinChinaNot yet recruiting
Local Institution - 0177Changchun, JilinChinaNot yet recruiting
Local Institution - 0179Shenyang, LiaoningChinaNot yet recruiting
Local Institution - 0242Shenyang, LiaoningChinaNot yet recruiting
Shandong Cancer HospitalJinan, ShandongChinaRecruiting
Local Institution - 0181Shanghai, Shanghai MunicipalityChinaNot yet recruiting
Local Institution - 0249Shanghai, Shanghai MunicipalityChinaNot yet recruiting
Local Institution - 0234Sichuan, SichuanChinaNot yet recruiting
Local Institution - 0182Tianjin, Tianjin MunicipalityChinaNot yet recruiting
Tianjin People' s HospitalTianjin, Tianjin MunicipalityChinaRecruiting
Local Institution - 0248Kunming, YunnanChinaNot yet recruiting
Local Institution - 0184Hangzhou, ZhejiangChinaNot yet recruiting
Local Institution - 0174ZhengzhouChinaNot yet recruiting
Local Institution - 0151Oulu, North OstrobothniaFinlandNot yet recruiting
Local Institution - 0152Turku, Southwest FinlandFinlandNot yet recruiting
Local Institution - 0150HelsinkiFinlandNot yet recruiting
CHU Bordeaux Haut-LevequePessac, AquitaineFranceRecruiting
Local Institution - 0044Saint-Cloud, Hauts-de-SeineFranceNot yet recruiting
Chu Saint EloiMontpellier, Languedoc-RoussillonFranceRecruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuNantes, Loire-AtlantiqueFranceRecruiting
Hopital Claude Huriez - CHU de LilleLille, NordFranceRecruiting
Local Institution - 0042Pierre-Bénite, RhôneFranceNot yet recruiting
Local Institution - 0191ParisFranceNot yet recruiting
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSEToulouseFranceRecruiting
Local Institution - 0163Ulm, Baden-WurttembergGermanyNot yet recruiting
Klinikum AugsburgAugsburg, BavariaGermanyRecruiting
Local Institution - 0220Göttingen, Lower SaxonyGermanyNot yet recruiting
GEFOS Gesellschaft f. onkologische StudienDortmund, North Rhine-WestphaliaGermanyRecruiting
Local Institution - 0193Düsseldorf, North Rhine-WestphaliaGermanyNot yet recruiting
Local Institution - 0231Münster, North Rhine-WestphaliaGermanyWithdrawn
Local Institution - 0232Münster, North Rhine-WestphaliaGermanyNot yet recruiting
Universitaetsklinikum des SaarlandesHomburg, SaarlandGermanyRecruiting
HELIOS Klinikum ErfurtErfurt, ThuringiaGermanyRecruiting
Universitätsklinikum JenaJena, ThuringiaGermanyRecruiting
Klinikum Chemnitz GgmbhChemnitzGermanyRecruiting
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, WolfDresdenGermanyRecruiting
Local Institution - 0162MünchenGermanyNot yet recruiting

60 more sites not listed.

+Investigators

  • Bristol Myers Squibb, Study director, Bristol-Myers Squibb