drugset / Trial / NCT01455506

PRO#0118: Decitabine Plus Mini Flu-Bu

NCT01455506

Phase 1 Completed 20 enrolled Hackensack Meridian Health
NaSingle-groupOpen-labelTreatment

Summary

This is a single institution study of combining decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation. A study population of 20 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will receive treatment with decitabine followed by reduced intensity fludarabine and busulfan prior to allogeneic stem cell transplantation. Subjects will be followed until 1 year post transplantation to assess stability of engraftment, toxicity, progression free survival, and disease response

Timeline

Start
2009-05
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 60 mg/m2 Intravenous
Background Busulfan Small molecule 130 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Thymoglobulin Protein / enzyme biologic 2 mg/kg Intravenous