Study Comparing Golcadomide and Rituximab with Other Treatments for Relapsed or Hard-to-Treat Follicular Lymphoma
Sponsor: Celgene
Sponsor score: 60
ClinicalTrials ID:NCT06911502
This clinical trial is testing a new combination of drugs, Golcadomide and Rituximab, against other treatments chosen by doctors for patients with follicular lymphoma that has returned or is difficult to treat.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to compare the effectiveness and safety of a new drug combination, Golcadomide and Rituximab, with other treatments selected by doctors for patients with follicular lymphoma that has come back or is not responding to previous treatments. Participants must have received at least one prior treatment for their lymphoma.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with follicular lymphoma (Grade 1, 2, or 3a) confirmed by a lab test.
- The lymphoma has returned after initial treatment or has not responded to the most recent treatment.
- Able to perform daily activities with little to no assistance (ECOG score 0-2).
- Have a PET scan showing active disease and at least one measurable tumor.
- Need treatment for lymphoma as determined by a doctor.
- Have had at least one previous treatment that included an anti-CD20 antibody (like Rituximab) and an alkylating agent (like Cyclophosphamide).
- Meet specific blood test requirements:
- Neutrophil count of at least 1,000 cells/mm³.
- Platelet count of at least 75,000 cells/mm³.
- Hemoglobin level of at least 7.5 g/dL.
- Kidney function with an eGFR of at least 30 ml/min/1.73m².
- Liver function tests within specified limits, with allowances for liver involvement by lymphoma or Gilbert's syndrome.
- Adequate heart function for those receiving certain chemotherapy, with a heart pumping ability of at least 40%.
Exclusion Criteria
- Have a history or evidence of other types of lymphoma, such as Diffuse Large B-Cell Lymphoma or transformed Non-Hodgkin Lymphoma.
- Have follicular large cell lymphoma or duodenal-type follicular lymphoma.
- Have any significant medical, lab, or psychiatric conditions that would interfere with the study.
- Have conditions that make it difficult to interpret study data.
- Have or had lymphoma affecting the central nervous system.
- Have had a stroke or brain bleeding in the last 6 months.
- Have had a blood clot in the last month.
- Have a history of a specific brain infection called progressive multifocal leukoencephalopathy.
- Have any other type of lymphoma.
- Have persistent diarrhea or absorption issues despite treatment.
- Have had another cancer that hasn't been in remission for at least 3 years, except for non-invasive cancers.
- Are resistant to both chemotherapy and lenalidomide, with specific criteria for resistance.
- Other criteria as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0014 | 36607 | Mobile | Alabama |
| Local Institution - 0074 | 99508 | Anchorage | Alaska |
| Local Institution - 0215 | 72205 | Little Rock | Arkansas |
| Local Institution - 0072 | 91010 | Duarte | California |
| Local Institution - 0119 | 94143 | San Francisco | California |
| Local Institution - 0008 | 32256 | Jacksonville | Florida |
| Local Institution - 0214 | 33606 | Tampa | Florida |
| Local Institution - 0217 | 33612 | Tampa | Florida |
| Local Institution - 0021 | 30060 | Marietta | Georgia |
| Local Institution - 0245 | 30265 | Newnan | Georgia |
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