Phase I Pilot Trial of Golcadomide With Pemetrexed, Rituximab, and Dexamethasone for Relapsed and Refractory CNS Lymphomas
Allison Winter
Summary
This research study is for people who have been diagnosed with large B-cell lymphoma of the central nervous system (CNS), which has either returned or is not responding to current treatment. Goldcadomide is a new experimental drug that works by binding to a specific protein inside cancer cells and helps stimulate immune cells that help fight cancer cells. It also has the ability to enter the central nervous system. It has shown promising safety and effectiveness when combined with standard of care chemotherapy. Participants will be treated with this study drug combined with standard of care chemotherapy. Participation in the research will last about 2.5 years. The purpose of this study is to help researchers learn if the study drug, Golcadomide, in combination with the standard of care regimen is a safe and effective way to treat large B-cell lymphoma with CNS involvement.
Description
People with systemic diffuse large B-cell lymphoma (DLCBL) can either have a a disease that involves the central nervous system or does not involve the central nervous system. The disease could also be only located in the central nervous system. The central nervous system lymphoma includes disease within the brain, meninges, cranial nerves, cerebrospinal fluid, spinal cord, and/or intraocular. For people with disease that involves the CNS it can be difficult to treat. This is because many effective lymphoma treatments do not cross the blood-brain barrier (BBB). In general there is a large unm…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants or their legally acceptable representative must have signed and dated an IRB approved written ICF in accordance with regulatory, local, and institutional guidelines. * Participants ≥ 18 years of age. * Confirmed histopathological diagnosis of aggressive malignant B-cell lymphoma based upon a representative histology specimen according to the WHO classification. For participants with secondary CNS lymphoma, this can be confirmed by prior systemic biopsy. If a CNS lesion was not amenable for biopsy, imaging (e.g. MRI Brain ± MRI Full Spine) with CSF analysis f…
Interventions
- DrugGolcadomide
To be taken orally daily on days 1-7 of the cycle Maximum 3 cycles but participants may received up to 3 additional cycles (for a total of up to 6 cycles) Cycle Length : 21 days Dose Levels: * Level -1 : 0.2milligrams/day * Level 1 : 0.2milligrams/day * Level 2 : 0.4milligrams/day
- DrugPemetrexed
To be given intravenously (IV) on day 1 of each cycle Maximum 3 cycles but participants may receive up to 3 additional cycles (for a total of up to 6 cycles) Cycle Length: 21 days Dose Level * Level -1 : 675 milligrams/square meter * Level 1 : 900 milligrams/square meter * Level 2 : 900 milligram/square meter
- DrugRituximab
To be given intravenously on day 1 of each cycle Maximum 3 cycles but participants may receive up to 3 additional cycles (for a total of up to 6 cycles) Cycle Length: 21 days Dose Level * Level -1 : 500 milligram/ square meter * Level 1 : 500 milligram/ square meter * Level 2 : 500 milligram/ square meter
- DrugDexamethasone
To be given orally on days 1-4 of each cycle Day 1 dose should be given at least 30 minutes before rituximab infusion Maximum 3 cycles but participants may receive up to 3 additional cycles (for a total of up to 6 cycles) Cycle Length: 21 days Dose Level * Level -1 : 10 milligrams * Level 1 : 10 milligrams * Level 2 : 10 milligrams
Location
- Cleveland Clinic, Case Comprehensive Cancer CenterCleveland, Ohio