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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 4

Conditions: Leukemia

Treatments: Drug: rabbit ATG（Sanofi/Genzyme）; Drug: Cytarabine(Actavis Italy S.p.A); Drug: Fludarabine (Bayer); Drug: granulocyte colony-stimulating factor (KirinKunpeng); Drug: Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)

Study type: Interventional

Funder types: Other

Identifiers

NCT02784561

81370666-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• relapsed/refractory acute leukemia regardless of cytogenetics
• All patients should aged 12 to 65 years
• Have matched sibling donors, ≥8/10 HLA(human leukocyte antigen) matched unrelated donors or haploidentical donors
• Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases

Exclusion criteria

• Patients aged less than 12 years old
• Patients with any uncontrolled infections or with severe pulmonary, renal, hepatic or cardiac diseases
• Acute myeloid leukemia patients with t (15;17)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Busulfan/FLAG conditioning regimen

Experimental group

Description:

All recipients in this arm received the conditioning regimen consisting of Busulfan/FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor). The conditioning regimen for peripheral blood stem cell transplantation consisted of busulfan (3.2 mg/kg/ day intravenously \[i.v.\], days -10 to -8), fludarabine (30 mg/m2, day -7 to -3), cytarabine (1.6 g/m2/day, days -7 to -3), granulocyte colony-stimulating factor (5 ug/ kg, day -8 to -3). ATG (Thymoglobuline, rabbit) for haploidentical and matched unrelated donors transplantation recipients was used on 2.5 mg/kg/d from days -5 to -2).

Treatment:

Drug: Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)

Drug: granulocyte colony-stimulating factor (KirinKunpeng)

Drug: Fludarabine (Bayer)

Drug: Cytarabine(Actavis Italy S.p.A)

Drug: rabbit ATG（Sanofi/Genzyme）