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 lymphomacancers of the lymphatic system who have received at least one line of prior systemic therapy.
Intervention / Treatment
- Drug: Golcadomide
- Drug: Rituximab
- Drug: Lenalidomide
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone/Prednisolone
- Drug: Bendamustine
Inclusion Criteria:
- Participant has histologically confirmed FL (Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 1, 2, or 3a) as assessed by local pathologythe study of disease. Adequate fresh tumor biopsyremoval of a section of tissue to analyse for cancer cells tissuea group of cells that work together to perform a function or archived tumor biopsy from the latest relapsethe return of disease if available with corresponding pathology report for retrospective central pathology confirmation of relapse, is required. Evaluation from fine needle aspirateto draw out fluid or tissue from the body, often with a syringe is not permitted.
- Relapsed or refractory disease:
- Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
- Refractory FL is defined as best response of SD or PD to the most recent prior therapy.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer 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 imagingtests that create detailed images of areas inside the body 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 antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses (eg, rituximab, obinutuzumab) and an alkylating agent (eg, cyclophosphamide, bendamustine). Prior treatment with radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells does not count as a line of therapy for eligibility.
- Lab parameters:
- Absolute neutrophil count (ANC) ≥ 1,000 cellsthe basic structural and functional unit of all living things/mm3 (1.0 x 109 /L),
- PLT count ≥ 75,000 cells/mm3 (75 x 109 /L)
- 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 dysfunctionimpaired or abnormal function; not working properly as per National Cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs 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 chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiograma type of ultrasound that uses sound waves to create detailed images of the heart to assess heart structure, function and blood flow (ECHO) as standard of care or multi-gated acquisition scan (MUGA)