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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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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

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Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Busulfan/FLAG conditioning regimen

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).

Group Type EXPERIMENTAL

Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)

Intervention Type DRUG

busulfan (3.2 mg/kg/day intravenously \[i.v.\], days -10 to -8)

Cytarabine(Actavis Italy S.p.A)

Intervention Type DRUG

cytarabine (1.6 g/m2/day, days -7 to -3)

Fludarabine (Bayer)

Intervention Type DRUG

fludarabine (30 mg/m2, day -7 to -3),

granulocyte colony-stimulating factor (KirinKunpeng)

Intervention Type DRUG

granulocyte colony-stimulating factor (5 ug/kg, day -8 to granulocyte recovery)

rabbit ATG（Sanofi/Genzyme）

Intervention Type DRUG

ATG; thymoglobuline, rabbit;2.5 mg/kg/day, days -5 to -2

Interventions

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Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)

busulfan (3.2 mg/kg/day intravenously \[i.v.\], days -10 to -8)

Intervention Type DRUG

Cytarabine(Actavis Italy S.p.A)

cytarabine (1.6 g/m2/day, days -7 to -3)

Intervention Type DRUG

Fludarabine (Bayer)

fludarabine (30 mg/m2, day -7 to -3),

Intervention Type DRUG

granulocyte colony-stimulating factor (KirinKunpeng)

granulocyte colony-stimulating factor (5 ug/kg, day -8 to granulocyte recovery)

Intervention Type DRUG

rabbit ATG（Sanofi/Genzyme）

ATG; thymoglobuline, rabbit;2.5 mg/kg/day, days -5 to -2

Intervention Type DRUG

Other Intervention Names

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Myleran, Busulfex Ara-C fludarabine phosphate (Fludara) G-CSF（granulocyte colony-stimulating factor ） Thymoglobuline

Eligibility Criteria

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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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No