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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02328950
Other study ID # FA5Bucy-SCT-01
Secondary ID
Status Recruiting
Phase N/A
First received December 28, 2014
Last updated February 16, 2016
Start date December 2014
Est. completion date December 2017

Study information

Verified date February 2016
Source Fujian Medical University
Contact Ting Yang, Prof.
Phone +86-591-83357896
Email yang.hopeting@gmail.com
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2017
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 65 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide
Fludarabine (F) 30 mg/m²/day for 5 days (day -12 to day-8) Cytarabine (A) 2g/m²/day for 5 days (day -12 to day-8) Bulsufan (Bu) 0.8mg/kg/day for 3 days (day -7 to day-5) Cyclophosphamide(Cy) 1.8g/m²/day for 3 days (day -4 to day-3)

Locations

Country Name City State
China Union Hospital,Fujian Medical University Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse rate at one year after allo-SCT one year Yes
Secondary Even free survival Overall Survival
Leukemia Free Survival
Graft Versus Host Disease
Regimen related toxicity
two year Yes
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