A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome

February 16, 2016 updated by: Ting YANG, Fujian Medical University

A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of FA as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Drug: Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

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

Study Locations

China
- Fujian
  - Fuzhou, Fujian, China, 350001
    - Recruiting
    - Union Hospital,Fujian Medical University
    - Principal Investigator:
      
      Jianda Hu, Dr.
    - Sub-Investigator:
      
      Ting Yang, Dr.

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

1 year to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with high-risk, recurrent or refractory acute leukemia and advanced myelodysplastic syndrome

Description

Inclusion Criteria:

Signed written informed consent
Aged between 0-65 years
Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1
Patients with advanced MDS
Cardiac: Left ventricular ejection fraction ≥ 50%
Adequate renal and hepatic function
Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

Pregnant or lactating females
Current participation in another clinical trial
Contra-indication to one of the drug of the regimen
Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relapse rate at one year after allo-SCT Time Frame: one year	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Even free survival Time Frame: two year	Overall Survival Leukemia Free Survival Graft Versus Host Disease Regimen related toxicity	two year

Collaborators and Investigators

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

Sponsor

Fujian Medical University

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

December 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 28, 2014

First Submitted That Met QC Criteria