drugset / Trial / NCT04447716

An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment

NCT04447716 ↗

Phase 1 Active not recruiting 4 enrolled Thomas Jefferson University Genentech, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of venetoclax when given together with lenalidomide and rituximab hyaluronidase in treating patients with follicular lymphoma and marginal zone lymphoma that has come back after treatment (relapsed) or has not responded to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking the action of a protein called Bcl-2, that helps cancer cells survive. Immunotherapy with lenalidomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as rituximab and rituximab hyaluronidase, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this research is to determine if the combination of three drugs, venetoclax, lenalidomide, and rituximab hyaluronidase are safe to administer in patients whose low-grade lymphoma (follicular or marginal zone) has come back after initial therapy or was not responsive to initial therapy.

Timeline

Start
2020-10-16
Primary completion
2024-05-16
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified — Oral
Subject Rituximab Monoclonal antibody — Intravenous
Subject Rituximab and Hyaluronidase Human Monoclonal antibody — Subcutaneous
Subject Venetoclax Small molecule — Oral