drugset / Trial / NCT04684979

Transplantation of Hematopoietic Stem Cells From HLA-compatible Donors in Patients With B-Cell Lymphoid Malignancies

NCT04684979 ↗

Phase 2 Withdrawn Baptist Health South Florida
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This research study is being conducted to treat patients with B-cell lymphoid malignancies. These types of cancers include diffuse large cell (DLBCL) non-Hodgkin's lymphoma (NHL), mantle cell NHL, any indolent B cell NHL (such as follicular, small cell or marginal zone NHL), or chronic lymphocytic leukemia (CLL). Patients with these types of lymphomas have been shown to benefit from peripheral blood stem cell transplantation (PBSCT). PBSCT uses healthy blood stem cells from a donor to replace your diseased or damaged bone marrow. Before undergoing PBSCT, you'll receive chemotherapy and/or radiation to destroy your diseased cells and prepare your body for the donor cells. This is called a "conditioning regimen." Non-myeloablative (NMA) conditioning causes minimal cell death. This research study will look at a course of treatment using NMA conditioning regimen including low dose chemotherapy and low dose radiation as well as rituximab and PBSCT from a compatible donor. The primary aim is to obtain a preliminary estimate of the overall and event-free survival 1 year post-transplant after NMA.

Timeline

Start
2022-03-28
Primary completion
2026-03
Completion
2027-03

Outcome

Outcome not reported

Stopped (Enrollment): “The landscape of treatment for patients targeted for enrollment has significantly changed since the protocol was written and approved, and the research treatment is no longer the best option for this population.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Hematopoietic Stem Cells from HLA Unrelated Cell therapy — —
Subject Hematopoietic Stem Cells from HLA-compatible Related Cell therapy — —
Background Rituximab Monoclonal antibody — —