NCT02328950

A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 1 Year – 65 Years
• Healthy volunteers: Not accepted

Summary

A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of FA as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.

Conditions

• Myelodysplastic Syndromes
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Type	Name	Description
DRUG	Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide	Fludarabine (F) 30 mg/m²/day for 5 days (day -12 to day-8) Cytarabine (A) 2g/m²/day for 5 days (day -12 to day-8) Bulsufan (Bu) 0.8mg/kg/day for 3 days (day -7 to day-5) Cyclophosphamide(Cy) 1.8g/m²/day for 3 days (day -4 to day-3)

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-09-01
• Completion: 2017-12-01
• First posted: 2014-12-31
• Last updated: 2016-02-17

Locations

1 site across 1 country: China