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

NCT02328950 | Unknown

• 1 other identifier: FA5Bucy-SCT-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Outcome Measures

Primary Outcomes (1)

• Relapse rate at one year after allo-SCT

  one year

Secondary Outcomes (1)

• Even free survival

  two year

Interventions

Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide DRUG

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)

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Union Hospital,Fujian Medical University

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Ting Yang, Prof.

CONTACT

+86-591-83357896; yang.hopeting@gmail.com

Jianda Hu, Prof.

CONTACT

+86-591-83357896; jdhu@medmail.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 28, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

CN (1)