Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients W
This phase I/II trial tests the safety and effectiveness of glofitamab (with obinutuzumab pretreatment), venetoclax, and lenalidomide in treating patients with newly diagnosed, high risk mantle cell lymphoma. Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to gr
| Condition(s) | Blastoid Variant Mantle Cell Lymphoma, Mantle Cell Lymphoma, Pleomorphic Variant Mantle Cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This phase I/II trial tests the safety and effectiveness of glofitamab (with obinutuzumab pretreatment), venetoclax, and lenalidomide in treating patients with newly diagnosed, high risk mantle cell lymphoma. Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Lenalidomide works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving venetoclax, glofitamab with obinutuzumab, and lenalidomide together may kill more cancer cells in patients with newly diagnosed, high risk mantl |
| Who can participate | Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: \>= 18 to 80 years * Eastern Cooperative Oncology Group =\< 2 * Diagnosis of MCL established by histologic assessment including one of the following: * Immunohistochemistry of the biopsy * Flow cytometry of the biopsy * Evidence of t(11;14) translocation involving the cyclin D1 gene by fluorescence in situ hybridization (FISH), and/or cyclin D1 expression by immunohistochemistry (IHC) unless disease is morphologically consistent with |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | City of Hope Medical Center |
| Locations | Duarte, California, United States; Salt Lake City, Utah, United States |
| Start date | 2023-08-10 |
| NCT ID | NCT05861050 |
| Official listing | https://clinicaltrials.gov/study/NCT05861050 |