About this trial
This phase I/II trial tests the safety, side effects, best dose and effectiveness of golcadomide in combination with rituximab in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving golcadomide in combination with rituximab may better treat patients with relapsed or refractory mantle cell lymphoma.
Eligibility criteria
Qualifiers
Documented informed consent of the participant and/or legally authorized representative
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Ability to adhere to the study protocol
Disqualifiers
Chemotherapy, radiation therapy (except for palliative radiation therapy [XRT]), biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy
Strong CYP3A4 inducers/ inhibitors within 14 days prior to day 1 of protocol therapy
Herbal medications
History of metastatic cancer
Trial design
Treatments tested in this trial
- Biopsy Procedure
- Biospecimen Collection
- Bone Marrow Biopsy
- Computed Tomography
- Golcadomide
- Positron Emission Tomography
- Rituximab
Treatment groups
Sponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator