Lymphoma, Follicular
Conditions
Keywords
Follicular lymphoma, Grade 1-3a Follicular lymphoma, BMS-986369, CC-99282, Lymphoma, golcadomide
Brief summary
The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
Interventions
DRUGGolcadomide
Specified dose on specified days
DRUGRituximab
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
DRUGDoxorubicin
Specified dose on specified days
DRUGVincristine
Specified dose on specified days
DRUGPrednisone
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 Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis. * Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable. * Stage II to IV disease. * Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:. i) Bulky disease defined as:. A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm). ii) Presence of at least one of the following B symptoms:. A. Fever (\>38°C) of unclear etiology. B. Night sweats. C. Weight loss greater than 10% within the prior 6 months. iii) Splenomegaly with inferior margin below the umbilical line. iv) Any one of the following cytopenia due to lymphoma:. A. Platelets \<100,000 cells/mm3 (100 x 109/L). B. Absolute neutrophil count (ANC) \< 1,000 cells/mm3 (1.0 x 109/L). C. Hemoglobin \< 10g/dL (6.25 mmol/L). v) Pleural or peritoneal serous effusion (irrespective of cell content). vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).
Exclusion criteria
* Clinical evidence of transformed lymphoma by investigator assessment. * Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification. * Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014 | Up to approximately 12 months from participant randomization | Golcadomide + Rituximab arms only |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0 | Up to 28 days after last dose | — |
| Best Overall Response (OR) | Up to approximately 12 months from participant randomization | Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014 |
| Duration of Response (DoR) | Up to approximately 3 years after randomization of the last participant | Defined as time from first confirmed response (Complete Response (CR) or Partial Response (PR)) to disease progression, start of new anti-lymphoma therapy, or death |
| Complete Response at 30 months (CR30) | At approximately 30 months from randomization | Defined as achieving CR based on Lugano criteria at 30 months from randomization |
| Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0 | Up to 28 days after last dose | — |
| Complete Metabolic Response at 12 months from the randomization (CMR12) | At approximately 12 months from randomization | Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization |
| Progression Free Survival (PFS) | Up to approximately 3 years from randomization of last participant | Defined as time from date of randomization to first occurrence of disease progression or death from any cause |
| Overall Survival (OS) | Up to approximately 3 years from randomization of last participant | Defined as time from date of randomization to death from any cause |
| Number of participants who achieve CMR as assessed by Lugano criteria 2014 | Up to approximately 6 months from randomization | Rituximab + Chemotherapy arm only |
| Complete Metabolic Response at 6 months from the randomization (CMR6) | At approximately 6 months from randomization | Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization |
Countries
Australia, Brazil, Canada, Chile, France, Germany, Italy, Poland, South Korea, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed