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.
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
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
Sequential
Biopsy Procedure
Procedure/SurgeryUndergo tissue biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow biopsy
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Golcadomide
DrugGiven PO
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Rituximab
Biological/VaccineGiven IV
Incidence of dose limiting toxicities (DLT)
The adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v 5.0). Toxicity will be summarized by type, severity, and attribution. DLT will be individually described.
Maximum tolerated dose (MTD) of golcadomide
If single agent is tolerable, we will subsequently explore golcadomide in combination with rituximab.
MTD of golcadomide in combination with rituximab
Patients would remain on therapy until unacceptable toxicity, treating physician discretion or PD.
Overall response rate (ORR)
Defined as achieving a best response of either complete metabolic response (CMR) or partial metabolic response (PMR) in a response-evaluable participant after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. ORR will be estimated by binary proportions, along with the 95% exact binomial confidence intervals.
Incidence of adverse events
Will be graded by NCI CTCAE v 5.0. Toxicity will be summarized by type, severity, and attribution.
Duration of response (DOR) of the combination of golcadomide and rituximab
DOR will be estimated using the product-limit method of Kaplan and Meier.
Duration of complete response (DOCR) of the combination of golcadomide and rituximab
DOCR will be estimated using the product-limit method of Kaplan and Meier.
Complete response (CR) of the combination of golcadomide and rituximab
CR rate will be estimated by binary proportions, along with the 95% exact binomial confidence intervals.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
