A Phase 1/2 Study of the CELMoD Agent Golcadomide in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma
City of Hope Medical Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerance of golcadomide in mantle cell lymphoma (MCL) patients who were resistant or intolerant to covalent bruton's tyrosine kinase inhibitors (cBTKi). II. To evaluate the safety and tolerance of golcadomide in combination with rituximab in MCL patients who were resistant or intolerant to cBTKi. III. To estimate the efficacy of golcadomide and rituximab in MCL patients who were resistant or intolerant to cBTKi. SECONDARY OBJECTIVES: I. To evaluate the complete response rate (CR) of the combination of golcadomide and rituximab. II. To ev…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Age: ≥ 18 years * Eastern Clinical Oncology Group (ECOG) ≤ 2 * Histologically confirmed diagnosis of MCL * Immunohistochemistry of the biopsy * Flow cytometry of the biopsy * Relapsed/ refractory disease * Relapsed/refractory (R/R) MCL after at least one line of the…
Interventions
- ProcedureBiopsy Procedure
Undergo tissue biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureComputed Tomography
Undergo PET/CT
- DrugGolcadomide
Given PO
- ProcedurePositron Emission Tomography
Undergo PET/CT
- BiologicalRituximab
Given IV
Location
- City of Hope Medical CenterDuarte, California