Golcadomide in Combination With Rituximab for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma
NCT07578077 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2026-05-11
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.
Conditions
- Recurrent Mantle Cell Lymphoma
- Refractory Mantle Cell Lymphoma
Interventions
- PROCEDURE
-
Biopsy Procedure
Undergo tissue biopsy
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Bone Marrow Biopsy
Undergo bone marrow biopsy
- PROCEDURE
-
Computed Tomography
Undergo PET/CT
- DRUG
-
Golcadomide
Given PO
- PROCEDURE
-
Positron Emission Tomography
Undergo PET/CT
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Tycel J Phillips · City of Hope Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-12-21
- Primary Completion
- 2030-04-21
- Completion
- 2030-04-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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