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

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02328950
• Other study ID #: FA5Bucy-SCT-01
• 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

• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia
• Syndrome

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