drugset / Trial / NCT01496547

Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML

NCT01496547

Phase 2 Completed 47 enrolled Shanghai Jiao Tong University School of Medicine
NaSingle-groupOpen-labelTreatment

Summary

Patients with refractory and relapse leukemia had poor outcome even with allogeneic stem cell transplantation. In our previous retrospective study, the overall survival is 14.6+/-8.8% while 90% patients eventually relapsed with marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. The accumulated TRM is 29.5+/-11.5%. Thus our data suggested that the conventional transplantation approach may not be able to overcome the refractory disease. A new strategy to combined a low dose regimen following intensive chemotherapy for tumor reduction seems to be effect in both relapsed. high-risk and refractory AML or ALL. In this study, we focus on a new treatment strategy for particular refractory AML patients.

Timeline

Start
2011-01
Primary completion
2018-02-28
Completion
2018-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 3.2 mg/kg Intravenous
Subject Cytarabine Small molecule 2000 mg/m2
Subject Fludarabine Small molecule 35 mg/m2
Subject Idarubicin Small molecule 12 mg/m2

Indications