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)
Cyclophosphamide: Specified dose on specified days
Doxorubicin: Specified dose on specified days
Vincristine: Specified dose on specified days
Prednisone/Prednisolone: Specified dose on specified days
Bendamustine: Specified dose on specified days
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC) — Up to approximately 32 Months
Trial sites (160)
Facility
City
Region
Status
Local Institution - 0225
Birmingham
Alabama
Not Yet Recruiting
Infirmary Cancer Care
Mobile
Alabama
Recruiting
Alaska Oncology and Hematology
Anchorage
Alaska
Recruiting
Local Institution - 0215
Little Rock
Arkansas
Not Yet Recruiting
City of Hope Comprehensive Cancer Center
Duarte
California
Recruiting
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco
California
Recruiting
Local Institution - 0008
Jacksonville
Florida
Not Yet Recruiting
Local Institution - 0214
Tampa
Florida
Not Yet Recruiting
Local Institution - 0217
Tampa
Florida
Not Yet Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta
Georgia
Recruiting
Southeastern Regional Medical Center
Newnan
Georgia
Recruiting
Local Institution - 0240
Arlington Heights
Illinois
Not Yet Recruiting
Local Institution - 0253
Iowa City
Iowa
Not Yet Recruiting
Local Institution - 0243
Waukee
Iowa
Not Yet Recruiting
Local Institution - 0216
Westwood
Kansas
Not Yet Recruiting
Local Institution - 0218
Lexington
Kentucky
Not Yet Recruiting
Local Institution - 0023
Baltimore
Maryland
Not Yet Recruiting
Greater Baltimore Medical Center
Towson
Maryland
Recruiting
Local Institution - 0145
Boston
Massachusetts
Not Yet Recruiting
Local Institution - 0244
Boston
Massachusetts
Not Yet Recruiting
Local Institution - 0247
Boston
Massachusetts
Not Yet Recruiting
Hattiesburg Clinic Hematology/Oncology
Hattiesburg
Mississippi
Recruiting
Local Institution - 0144
Providence
Rhode Island
Not Yet Recruiting
Texas Oncology - Central/South Texas
Austin
Texas
Recruiting
Local Institution - 0212
Fort Worth
Texas
Not Yet Recruiting
Local Institution - 0230
San Antonio
Texas
Not Yet Recruiting
Texas Oncology - Northeast Texas
Tyler
Texas
Recruiting
Local Institution - 0238
Fairfax
Virginia
Not Yet Recruiting
Hematology Oncology Associates of Fredericksburg
Fredericksburg
Virginia
Recruiting
Blue Ridge Cancer Care
Roanoke
Virginia
Recruiting
Local Institution - 0143
Vancouver
Washington
Not Yet Recruiting
Westmead Hospital
Westmead
New South Wales
Recruiting
Local Institution - 0132
Adelaide
South Australia
Not Yet Recruiting
Local Institution - 0131
Hobart
Tasmania
Not Yet Recruiting
Local Institution - 0128
Heidelberg
Victoria
Not Yet Recruiting
Cabrini Hospital - Malvern
Malvern
Victoria
Recruiting
Local Institution - 0127
Perth
Western Australia
Not Yet Recruiting
Local Institution - 0224
Perth
Western Australia
Withdrawn
Local Institution - 0159
Vitória
Espírito Santo
Not Yet Recruiting
Local Institution - 0088
Niterói
Rio de Janeiro
Not Yet Recruiting
+ 120 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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