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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328950
Recruitment Status : Unknown
Verified February 2016 by Ting YANG, Fujian Medical University.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Ting YANG, Fujian Medical University

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.

Condition or disease Intervention/treatment
Myelodysplastic Syndromes Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma Drug: Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : December 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2017



Intervention Details:
  • 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)


Primary Outcome Measures :
  1. Relapse rate at one year after allo-SCT [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Even free survival [ Time Frame: two year ]
    • Overall Survival
    • Leukemia Free Survival
    • Graft Versus Host Disease
    • Regimen related toxicity



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with high-risk, recurrent or refractory acute leukemia and advanced myelodysplastic syndrome
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328950


Contacts
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Contact: Ting Yang, Prof. +86-591-83357896 ext 8041 yang.hopeting@gmail.com
Contact: Jianda Hu, Prof. +86-591-83357896 ext 8041 jdhu@medmail.com.cn

Locations
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China, Fujian
Union Hospital,Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350001
Contact: Ting Yang, Prof.    +86-591-83357896 ext 8041    yang.hopeting@gmail.com   
Contact: Jianda Hu, Prof.    +86-591-83357896 ext 8041    jdhu@medmail.com.cn   
Principal Investigator: Jianda Hu, Dr.         
Sub-Investigator: Ting Yang, Dr.         
Sponsors and Collaborators
Fujian Medical University
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Responsible Party: Ting YANG, Prof. Dr., Fujian Medical University
ClinicalTrials.gov Identifier: NCT02328950    
Other Study ID Numbers: FA5Bucy-SCT-01
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Cyclophosphamide
Busulfan
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action