Clinical trial 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 (GOLSEEK-4)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Follicular Lymphoma
Keywords: Follicular Lymphoma
Second Line Follicular Lymphoma
Third Line Follicular Lymphoma
Relapsed/refractory follicular lymphoma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* Relapsed or refractory disease:

  1. Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
  2. Refractory FL is defined as best response of SD or PD 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:

  1. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L),
  2. PLT count ≥ 75,000 cells/mm3 (75 x 109 /L)
  3. 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) ≥ 40% 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) 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.
* Participants who are refractory to both chemotherapies as well as lenalidomide, defined as:

  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
  2. SD/progressive disease as best response to lenalidomide based regimen or a response to lenalidomide based regimen that lasted less than 6 months.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)
timeFrame: Up to approximately 32 Months
Secondary outcomes:
measure: Overall response rate (ORR) assessed by IRAC
timeFrame: Up to approximately 32 Months
measure: Overall survival (OS)
timeFrame: Up to approximately 83 Months
measure: PFS as assessed by investigator
timeFrame: Up to approximately 32 Months
measure: ORR as assessed by investigator
timeFrame: Up to approximately 32 Months
measure: Number of participants who achieve complete metabolic response (CMR)
timeFrame: Up to approximately 32 Months
measure: Duration of Response (DoR)
timeFrame: Up to approximately 32 Months
measure: Event free survival (EFS)
timeFrame: Up to approximately 32 Months
measure: Time to next anti-lymphoma treatment (TTNT)
timeFrame: Up to approximately 32 Months
measure: PFS on next anti-lymphoma treatment (PFS2)
timeFrame: Up to approximately 32 Months
measure: 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
timeFrame: Up to approximately 32 Months
measure: 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
timeFrame: Up to approximately 32 Months
measure: Minimal residual disease (MRD) negativity
timeFrame: Up to approximately 32 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0225
state: Alabama
city: Mobile
country: United States
facility: Local Institution - 0014
state: Alabama
city: Anchorage
country: United States
facility: Local Institution - 0074
state: Alaska
city: Little Rock
country: United States
facility: Local Institution - 0215
state: Arkansas
city: Duarte
country: United States
facility: Local Institution - 0072
state: California
city: San Francisco
country: United States
facility: Local Institution - 0119
state: California
city: Jacksonville
country: United States
facility: Local Institution - 0008
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0214
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0217
state: Florida
city: Marietta
country: United States
facility: Local Institution - 0021
state: Georgia
city: Newnan
country: United States
facility: Local Institution - 0245
state: Georgia
city: Arlington Heights
country: United States
facility: Local Institution - 0240
state: Illinois
city: Waukee
country: United States
facility: Local Institution - 0243
state: Iowa
city: Westwood
country: United States
facility: Local Institution - 0216
state: Kansas
city: Lexington
country: United States
facility: Local Institution - 0218
state: Kentucky
city: Baltimore
country: United States
facility: Local Institution - 0023
state: Maryland
city: Towson
country: United States
facility: Local Institution - 0010
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0145
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0244
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0247
state: Massachusetts
city: Hattiesburg
country: United States
facility: Local Institution - 0013
state: Mississippi
city: Providence
country: United States
facility: Local Institution - 0144
state: Rhode Island
city: Austin
country: United States
facility: Local Institution - 0237
state: Texas
city: Fort Worth
country: United States
facility: Local Institution - 0212
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0230
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0236
state: Texas
city: Fredericksburg
country: United States
facility: Local Institution - 0030
state: Virginia
city: Roanoke
country: United States
facility: Local Institution - 0146
state: Virginia
city: Vancouver
country: United States
facility: Local Institution - 0143
state: Washington
city: Westmead
country: Australia
facility: Local Institution - 0134
state: New South Wales
city: Adelaide
country: Australia
facility: Local Institution - 0132
state: South Australia
city: Hobart
country: Australia
facility: Local Institution - 0131
state: Tasmania
city: Heidelberg
country: Australia
facility: Local Institution - 0128
state: Victoria
city: Malvern
country: Australia
facility: Local Institution - 0198
state: Victoria
city: Perth
country: Australia
facility: Local Institution - 0127
state: Western Australia
city: Perth
country: Australia
facility: Local Institution - 0224
state: Western Australia
city: Vitoria
country: Brazil
facility: Local Institution - 0159
state: Espírito Santo
city: Niterói
country: Brazil
facility: Local Institution - 0088
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Local Institution - 0087
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Local Institution - 0079
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0089
city: São Paulo
country: Brazil
facility: Local Institution - 0066
city: São Paulo
country: Brazil
facility: Local Institution - 0092
city: Victoria
country: Canada
facility: Local Institution - 0200
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 0035
state: Ontario
city: Sherbrooke
country: Canada
facility: Local Institution - 0192
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution - 0226
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0154
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0155
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0153
state: Región Metropolitana De Santiago
city: Beijing
country: China
facility: Local Institution - 0246
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0171
state: Beijing
city: Fuzhou Fujian
country: China
facility: Local Institution - 0172
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0173
state: Guangdong
city: Harbin
country: China
facility: Local Institution - 0241
state: Heilongjiang
city: Wuhan
country: China
facility: Local Institution - 0176
state: Hubei
city: Changsha
country: China
facility: Local Institution - 0175
state: Hunan
city: Hohhot
country: China
facility: Local Institution - 0235
state: Inner Mongolia
city: Suzhou
country: China
facility: Local Institution - 0233
state: Jiangsu
city: Nanchang
country: China
facility: Local Institution - 0178
state: Jiangxi
city: Changchun
country: China
facility: Local Institution - 0239
state: Jilin
city: Changchun
country: China
facility: Local Institution - 0177
state: Jilin
city: Shenyang
country: China
facility: Local Institution - 0179
state: Liaoning
city: Shenyang
country: China
facility: Local Institution - 0242
state: Liaoning
city: Jinan
country: China
facility: Local Institution - 0180
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0181
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0249
state: Shanghai
city: Sichuan
country: China
facility: Local Institution - 0234
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0182
state: Tianjin
city: Tianjin
country: China
facility: Local Institution - 0227
state: Tianjin
city: Kunming
country: China
facility: Local Institution - 0248
state: Yunnan
city: Hangzhou
country: China
facility: Local Institution - 0184
state: Zhejiang
city: Zhengzhou
country: China
facility: Local Institution - 0174
city: Oulu
country: Finland
facility: Local Institution - 0151
state: Pohjois-Pohjanmaa
city: Turku
country: Finland
facility: Local Institution - 0152
state: Varsinais-Suomi
city: Helsinki
country: Finland
facility: Local Institution - 0150
city: Pessac
country: France
facility: Local Institution - 0100
state: Aquitaine
city: Toulouse
country: France
facility: Local Institution - 0121
state: Haute-Garonne
city: Saint-Cloud
country: France
facility: Local Institution - 0044
state: Hauts-de-Seine
city: Montpellier
country: France
facility: Local Institution - 0047
state: Hérault
city: Nantes
country: France
facility: Local Institution - 0120
state: Loire-Atlantique
city: Lille
country: France
facility: Local Institution - 0048
state: Nord
city: Pierre-Bénite
country: France
facility: Local Institution - 0042
state: Rhône
city: Paris
country: France
facility: Local Institution - 0191
city: Ulm
country: Germany
facility: Local Institution - 0163
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Local Institution - 0161
state: Bayern
city: Göttingen
country: Germany
facility: Local Institution - 0220
state: Niedersachsen
city: Dortmund
country: Germany
facility: Local Institution - 0166
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Local Institution - 0193
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Local Institution - 0231
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Local Institution - 0232
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Local Institution - 0164
state: Saarland
city: Chemnitz
country: Germany
facility: Local Institution - 0165
state: Sachsen
city: Erfurt
country: Germany
facility: Local Institution - 0222
state: Thüringen
city: Jena
country: Germany
facility: Local Institution - 0167
state: Thüringen
city: Dresden
country: Germany
facility: Local Institution - 0187
city: München
country: Germany
facility: Local Institution - 0162
city: Wuerzburg
country: Germany
facility: Local Institution - 0221
city: Athens
country: Greece
facility: Local Institution - 0109
state: Attikí
city: Αthens
country: Greece
facility: Local Institution - 0107
state: Attikí
city: Thessaloniki
country: Greece
facility: Local Institution - 0110
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: Local Institution - 0197
state: Thessaloníki
city: Alexandroupolis
country: Greece
facility: Local Institution - 0111
city: Ioannina
country: Greece
facility: Local Institution - 0108
state: Ípeiros
city: New Delhi
country: India
facility: Local Institution - 0142
state: Delhi
city: Bengaluru
country: India
facility: Local Institution - 0139
state: Karnataka
city: Mumbai
country: India
facility: Local Institution - 0141
state: Maharashtra
city: Hyderabad
country: India
facility: Local Institution - 0140
state: Telangana
city: Hyderabad
country: India
facility: Local Institution - 0138
state: Telangana
city: Bologna
country: Italy
facility: Local Institution - 0104
state: Emilia-Romagna
city: Meldola
country: Italy
facility: Local Institution - 0101
state: Emilia-Romagna
city: Rozzano
country: Italy
facility: Local Institution - 0103
state: Milano
city: Pisa
country: Italy
facility: Local Institution - 0106
state: Toscana
city: Alessandria
country: Italy
facility: Local Institution - 0102
city: Napoli
country: Italy
facility: Local Institution - 0105
city: Torino
country: Italy
facility: Local Institution - 0157
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0059
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0060
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0061
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0058
state: Seoul-teukbyeolsi [Seoul]
city: Amsterdam
country: Netherlands
facility: Local Institution - 0050
state: Noord-Holland
city: Groningen
country: Netherlands
facility: Local Institution - 0046
city: Utrecht
country: Netherlands
facility: Local Institution - 0053
city: Warszawa
country: Poland
facility: Local Institution - 0188
state: Mazowieckie
city: Kraków
country: Poland
facility: Local Institution - 0186
state: Małopolskie
city: Gdynia
country: Poland
facility: Local Institution - 0190
state: Pomorskie
city: Skórzewo
country: Poland
facility: Local Institution - 0185
state: Wielkopolskie
city: Łódź
country: Poland
facility: Local Institution - 0189
state: Łódzkie
city: Dammam
country: Saudi Arabia
facility: Local Institution - 0099
state: Ash Sharqīyah
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 0054
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 0052
city: Sabadell
country: Spain
facility: Local Institution - 0158
state: Barcelona [Barcelona]
city: Santander
country: Spain
facility: Local Institution - 0122
state: Cantabria
city: Madrid
country: Spain
facility: Local Institution - 0124
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Local Institution - 0125
state: Valenciana, Comunitat
city: Granada
country: Spain
facility: Local Institution - 0126
city: Madrid
country: Spain
facility: Local Institution - 0123
city: Istanbul- Fatih
country: Turkey
facility: Local Institution - 0195
state: İstanbul
city: Ankara
country: Turkey
facility: Local Institution - 0194
city: Antalya
country: Turkey
facility: Local Institution - 0196
city: Mersin
country: Turkey
facility: Local Institution - 0223
city: Cringleford
country: United Kingdom
facility: Local Institution - 0148
state: England
city: Canterbury
country: United Kingdom
facility: Local Institution - 0147
state: Kent
city: London
country: United Kingdom
facility: Local Institution - 0213
state: London, City Of
city: Manchester
country: United Kingdom
facility: Local Institution - 0149
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: