NCT02784561

Study of Busulfan and FLAG Conditioning Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation

Safety and Efficacy Study of Busulfan/FLAG Conditioning Regimen in Patients With Relapsed/Refractory Acute Leukemia Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of Busulfan/FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor) Conditioning Regimen in Patients with Relapsed/refractory Acute Leukemia undergoing allogeneic peripheral blood stem cell transplantation.

Detailed description

Allogeneic hematopoietic stem cell transplantation (allo-SCT) is the only way to cure relapsed/refractory acute leukemia. Busulfan/Cyclophosphamide (BuCy, Cytarabine, Busulfan, Cyclophosphamide) has been a classical conditioning regimen for allo-SCT. Substitution of Cyclophosphamide in the BuCy regimen with Fludarabine (BuF) resulted in reduced toxicity and similar efficacy. FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor) is a chemotherapy regimen that has been proved to be effective for relapsed/refractory acute leukemia as salvage therapy. To reduce the relapse and improve the survival of those patients with relapsed/refractory acute leukemia who receive allo-SCT, the novel conditioning regimen consisting of Busulfan/FLAG was developed. The combination of Bu and FLAG without interval shortens the duration of conditioning and the pneutropenic period of the patient compared with successive administration of FLAG followed with BuF. In addition, regarding the established safety and efficacy of BuF and FLAG, it is reasonable to expect similar safety and enhanced antileukemic efficacy for Bu/FLAG compared with BuF. In this study, the safety and efficacy of this regimen in patients with relapsed/refractory acute leukemia undergoing allogeneic peripheral blood stem cell transplantation was investigated.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)	busulfan (3.2 mg/kg/day intravenously \[i.v.\], days -10 to -8)
DRUG	Cytarabine(Actavis Italy S.p.A)	cytarabine (1.6 g/m2/day, days -7 to -3)
DRUG	Fludarabine (Bayer)	fludarabine (30 mg/m2, day -7 to -3),
DRUG	granulocyte colony-stimulating factor (KirinKunpeng)	granulocyte colony-stimulating factor (5 ug/kg, day -8 to granulocyte recovery)
DRUG	rabbit ATG（Sanofi/Genzyme）	ATG; thymoglobuline, rabbit;2.5 mg/kg/day, days -5 to -2

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-07-01
• Completion: 2020-07-01
• First posted: 2016-05-27
• Last updated: 2016-05-27