drugset / Trial / NCT07565220

Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies

NCT07565220

Phase 1 Recruiting 48 enrolled Sawa Ito, MD
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).

Timeline

Start
2026-08-01
Primary completion
2029-06-01
Completion
2030-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fludarabine Small molecule 30 mg/m2
Subject Fludarabine Small molecule 40 mg/m2
Background Busulfan Small molecule 3.2 mg/kg Intravenous
Background Thiotepa Other / unclassified 5 mg/kg