drugset / Trial / NCT05031897

Two Step Haplo With Radiation Conditioning

NCT05031897 ↗

Phase 2 Recruiting 63 enrolled Thomas Jefferson University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.

Timeline

Start
2021-10-25
Primary completion
2032-04
Completion
2032-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous
Background Mycophenolate Mofetil Small molecule — Intravenous
Background Tacrolimus Small molecule — Intravenous