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
| Registry | NCT06911502 |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 400 (Estimated) |
| Sponsor | Celgene (Industry) |
| Conditions | Follicular Lymphoma |
| Interventions | Golcadomide, Rituximab, Lenalidomide, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone, Bendamustine (Drug) |
| Dates | start 2025-07-28, primary completion 2028-04-24 (estimated), completion 2030-07-31 (estimated), first posted 2025-04-04, last updated 2026-05-20 |
| Locations | 160 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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Golcadomide + Rituximab | Experimental | Drug: Golcadomide; Drug: Rituximab | |
| Rituximab + Lenalidomide/Chemotherapy | Active comparator | Drug: Rituximab; Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone; Drug: Bendamustine | Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Local Institution - 0225 | Birmingham, Alabama | United States | Not yet recruiting |
| Infirmary Cancer Care | Mobile, Alabama | United States | Recruiting |
| Alaska Oncology and Hematology | Anchorage, Alaska | United States | Recruiting |
| Local Institution - 0215 | Little Rock, Arkansas | United States | Not yet recruiting |
| City of Hope Comprehensive Cancer Center | Duarte, California | United States | Recruiting |
| UCSF Helen Diller Medical Center at Parnassus Heights | San Francisco, California | United States | Recruiting |
| Local Institution - 0008 | Jacksonville, Florida | United States | Not yet recruiting |
| Local Institution - 0214 | Tampa, Florida | United States | Not yet recruiting |
| Local Institution - 0217 | Tampa, Florida | United States | Not yet recruiting |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Marietta, Georgia | United States | Recruiting |
| Southeastern Regional Medical Center | Newnan, Georgia | United States | Recruiting |
| Local Institution - 0240 | Arlington Heights, Illinois | United States | Not yet recruiting |
| Local Institution - 0253 | Iowa City, Iowa | United States | Not yet recruiting |
| Local Institution - 0243 | Waukee, Iowa | United States | Not yet recruiting |
| Local Institution - 0216 | Westwood, Kansas | United States | Not yet recruiting |
| Local Institution - 0218 | Lexington, Kentucky | United States | Not yet recruiting |
| Local Institution - 0023 | Baltimore, Maryland | United States | Not yet recruiting |
| Greater Baltimore Medical Center | Towson, Maryland | United States | Recruiting |
| Local Institution - 0145 | Boston, Massachusetts | United States | Not yet recruiting |
| Local Institution - 0244 | Boston, Massachusetts | United States | Not yet recruiting |
| Local Institution - 0247 | Boston, Massachusetts | United States | Not yet recruiting |
| Hattiesburg Clinic Hematology/Oncology | Hattiesburg, Mississippi | United States | Recruiting |
| Local Institution - 0144 | Providence, Rhode Island | United States | Not yet recruiting |
| Texas Oncology - Central/South Texas | Austin, Texas | United States | Recruiting |
| Local Institution - 0212 | Fort Worth, Texas | United States | Not yet recruiting |
| Local Institution - 0230 | San Antonio, Texas | United States | Not yet recruiting |
| Texas Oncology - Northeast Texas | Tyler, Texas | United States | Recruiting |
| Local Institution - 0238 | Fairfax, Virginia | United States | Not yet recruiting |
| Hematology Oncology Associates of Fredericksburg | Fredericksburg, Virginia | United States | Recruiting |
| Blue Ridge Cancer Care | Roanoke, Virginia | United States | Recruiting |
| Local Institution - 0143 | Vancouver, Washington | United States | Not yet recruiting |
| Westmead Hospital | Westmead, New South Wales | Australia | Recruiting |
| Local Institution - 0132 | Adelaide, South Australia | Australia | Not yet recruiting |
| Local Institution - 0131 | Hobart, Tasmania | Australia | Not yet recruiting |
| Local Institution - 0128 | Heidelberg, Victoria | Australia | Not yet recruiting |
| Cabrini Hospital - Malvern | Malvern, Victoria | Australia | Recruiting |
| Local Institution - 0127 | Perth, Western Australia | Australia | Not yet recruiting |
| Local Institution - 0224 | Perth, Western Australia | Australia | Withdrawn |
| Local Institution - 0159 | Vitória, Espírito Santo | Brazil | Not yet recruiting |
| Local Institution - 0088 | Niterói, Rio de Janeiro | Brazil | Not yet recruiting |
| Local Institution - 0087 | Porto Alegre, Rio Grande do Sul | Brazil | Not yet recruiting |
| Local Institution - 0079 | São Paulo, São Paulo | Brazil | Not yet recruiting |
| Local Institution - 0089 | Rio de Janeiro | Brazil | Not yet recruiting |
| Local Institution - 0066 | São Paulo | Brazil | Not yet recruiting |
| Local Institution - 0092 | São Paulo | Brazil | Not yet recruiting |
| Local Institution - 0200 | Victoria, British Columbia | Canada | Not yet recruiting |
| Princess Margaret Cancer Centre | Toronto, Ontario | Canada | Recruiting |
| Local Institution - 0250 | Québec, Quebec | Canada | Not yet recruiting |
| Local Institution - 0192 | Sherbrooke, Quebec | Canada | Not yet recruiting |
| Local Institution - 0226 | Sherbrooke, Quebec | Canada | Withdrawn |
| Local Institution - 0154 | Santiago, Santiago Metropolitan | Chile | Not yet recruiting |
| Local Institution - 0155 | Santiago, Santiago Metropolitan | Chile | Not yet recruiting |
| Local Institution - 0153 | Santiago, Santiago Metropolitan | Chile | Not yet recruiting |
| Local Institution - 0246 | Beijing, Beijing Municipality | China | Not yet recruiting |
| Beijing Cancer hospital | Beijing, Beijing Municipality | China | Recruiting |
| Local Institution - 0172 | Fuzhou Fujian, Fujian | China | Not yet recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou, Guangdong | China | Recruiting |
| Local Institution - 0241 | Harbin, Heilongjiang | China | Not yet recruiting |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan, Hubei | China | Recruiting |
| Local Institution - 0175 | Changsha, Hunan | China | Not yet recruiting |
| Inner Mongolia Cancer Hospital | Hohhot, Inner Mongolia | China | Recruiting |
| Local Institution - 0233 | Suzhou, Jiangsu | China | Not yet recruiting |
| Local Institution - 0178 | Nanchang, Jiangxi | China | Not yet recruiting |
| Local Institution - 0239 | Changchun, Jilin | China | Not yet recruiting |
| Local Institution - 0177 | Changchun, Jilin | China | Not yet recruiting |
| Local Institution - 0179 | Shenyang, Liaoning | China | Not yet recruiting |
| Local Institution - 0242 | Shenyang, Liaoning | China | Not yet recruiting |
| Shandong Cancer Hospital | Jinan, Shandong | China | Recruiting |
| Local Institution - 0181 | Shanghai, Shanghai Municipality | China | Not yet recruiting |
| Local Institution - 0249 | Shanghai, Shanghai Municipality | China | Not yet recruiting |
| Local Institution - 0234 | Sichuan, Sichuan | China | Not yet recruiting |
| Local Institution - 0182 | Tianjin, Tianjin Municipality | China | Not yet recruiting |
| Tianjin People' s Hospital | Tianjin, Tianjin Municipality | China | Recruiting |
| Local Institution - 0248 | Kunming, Yunnan | China | Not yet recruiting |
| Local Institution - 0184 | Hangzhou, Zhejiang | China | Not yet recruiting |
| Local Institution - 0174 | Zhengzhou | China | Not yet recruiting |
| Local Institution - 0151 | Oulu, North Ostrobothnia | Finland | Not yet recruiting |
| Local Institution - 0152 | Turku, Southwest Finland | Finland | Not yet recruiting |
| Local Institution - 0150 | Helsinki | Finland | Not yet recruiting |
| CHU Bordeaux Haut-Leveque | Pessac, Aquitaine | France | Recruiting |
| Local Institution - 0044 | Saint-Cloud, Hauts-de-Seine | France | Not yet recruiting |
| Chu Saint Eloi | Montpellier, Languedoc-Roussillon | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu | Nantes, Loire-Atlantique | France | Recruiting |
| Hopital Claude Huriez - CHU de Lille | Lille, Nord | France | Recruiting |
| Local Institution - 0042 | Pierre-Bénite, Rhône | France | Not yet recruiting |
| Local Institution - 0191 | Paris | France | Not yet recruiting |
| Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE | Toulouse | France | Recruiting |
| Local Institution - 0163 | Ulm, Baden-Wurttemberg | Germany | Not yet recruiting |
| Klinikum Augsburg | Augsburg, Bavaria | Germany | Recruiting |
| Local Institution - 0220 | Göttingen, Lower Saxony | Germany | Not yet recruiting |
| GEFOS Gesellschaft f. onkologische Studien | Dortmund, North Rhine-Westphalia | Germany | Recruiting |
| Local Institution - 0193 | Düsseldorf, North Rhine-Westphalia | Germany | Not yet recruiting |
| Local Institution - 0231 | Münster, North Rhine-Westphalia | Germany | Withdrawn |
| Local Institution - 0232 | Münster, North Rhine-Westphalia | Germany | Not yet recruiting |
| Universitaetsklinikum des Saarlandes | Homburg, Saarland | Germany | Recruiting |
| HELIOS Klinikum Erfurt | Erfurt, Thuringia | Germany | Recruiting |
| Universitätsklinikum Jena | Jena, Thuringia | Germany | Recruiting |
| Klinikum Chemnitz Ggmbh | Chemnitz | Germany | Recruiting |
| Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf | Dresden | Germany | Recruiting |
| Local Institution - 0162 | München | Germany | Not yet recruiting |
60 more sites not listed.