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

NCT02784561 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-05-27

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • 309th Hospital of Chinese People's Liberation Army

    collaborator OTHER

  • Beijing Naval General Hospital

    collaborator OTHER

  • Space Center Hospital, Peking University

    collaborator UNKNOWN

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Daihong Liu, Doctor · Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-07-31
Completion
2020-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02784561 on ClinicalTrials.gov