Phase 1Active, not recruiting
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
A Phase I Study of Venetoclax + Lenalidomide + Rituximab Hyaluronidase in Relapsed or Refractory (R/R) Indolent Non-Hodgkin's Lymphoma (iNHL).
- Sponsor
- Thomas Jefferson University (Academic or other)
- Enrolment
- 4 enrolled
- Conditions
- Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Follicular Lymphoma; Recurrent Indolent Adult Non-Hodgkin Lymphoma; Recurrent Marginal Zone Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Follicular Lymphoma; Refractory Indolent Adult Non-Hodgkin Lymphoma; Refractory Marginal Zone Lymphoma
- Interventions
- Venetoclax; Lenalidomide; Rituximab; Rituximab and Hyaluronidase Human
- Ages
- adults, older adults
- Registry
- NCT04447716
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Rate of dose-limiting toxicities
History
Study completion expected
Last registry update
Primary completion
Started
Registered