drugset
drugset / Trial / NCT01010217

Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide

NCT01010217 ↗

Phase 2 Completed 176 enrolled M.D. Anderson Cancer Center
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn about the safety of giving a stem cell transplant from a tissue-mismatched donor, followed by cyclophosphamide, to patients with certain types of blood disorders or blood cancers. Melphalan, thiotepa, and fludarabine will also be given before the transplant. Researchers will study the health status of these patients at 3 months after the transplant.

Timeline

Start
2009-11-05
Primary completion
2017-10-05
Completion
2017-10-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 10 mg/kg Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous
Background G-CSF Unknown 5 ug/kg Subcutaneous
Background Melphalan Small molecule 100 mg/m2 Intravenous
Background Melphalan Small molecule 140 mg/m2 Intravenous
Background Mycophenolate Mofetil Small molecule 15 mg/kg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 1000 mg/m2 Intravenous
Background Tacrolimus Small molecule 0.015 mg/kg Intravenous
Background Thiotepa Other / unclassified 5 mg/kg Intravenous

Indications

disease related to hematopoietic stem cell transplant leukemia