Follicular Lymphoma
Conditions
Keywords
Follicular Lymphoma, Second Line Follicular Lymphoma, Third Line Follicular Lymphoma, Relapsed/refractory follicular lymphoma
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.
Interventions
DRUGGolcadomide
Specified dose on specified days
DRUGRituximab
Specified dose on specified days
DRUGLenalidomide
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
DRUGDoxorubicin
Specified dose on specified days
DRUGVincristine
Specified dose on specified days
Specified dose on specified days
DRUGBendamustine
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 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 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: 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) ≥ 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) 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC) | Up to approximately 32 Months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Overall response rate (ORR) assessed by IRAC | 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 |
| Event free survival (EFS) | Up to approximately 32 Months |
Countries
Australia, Brazil, Canada, Chile, China, Finland, France, Germany, Greece, India, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Korea, Spain, Turkey (Türkiye), United Arab Emirates, United Kingdom, United States
Contacts
Primary ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Backup ContactFirst line of the email MUST contain the NCT# and Site #.
Outcome results
None listed