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

May 24, 2016 updated by: Daihong Liu, Chinese PLA General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)
busulfan (3.2 mg/kg/day intravenously [i.v.], days -10 to -8)
Other Names:
  • Myleran, Busulfex
Drug: Cytarabine(Actavis Italy S.p.A)
cytarabine (1.6 g/m2/day, days -7 to -3)
Other Names:
  • Ara-C
Drug: Fludarabine (Bayer)
fludarabine (30 mg/m2, day -7 to -3),
Other Names:
  • fludarabine phosphate (Fludara)
Drug: granulocyte colony-stimulating factor (KirinKunpeng)
granulocyte colony-stimulating factor (5 ug/kg, day -8 to granulocyte recovery)
Other Names:
  • G-CSF（granulocyte colony-stimulating factor ）
Drug: rabbit ATG（Sanofi/Genzyme）
ATG; thymoglobuline, rabbit;2.5 mg/kg/day, days -5 to -2
Other Names:
  • Thymoglobuline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)
Time Frame: three months
three months
Rate of Complete Remission as assessed by NCCN (National Comprehensive Cancer Network )criteria
Time Frame: 30 days
30 days
DFS(disease-free survival )
Time Frame: two years
two years
TRM(treatment-related mortality )
Time Frame: two years
two years
Number of participants with Regimen-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

309th Hospital of Chinese People's Liberation Army
Beijing Naval General Hospital
Space Center Hospital, Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81370666-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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