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Study of New RIC Regimen of BuFlu in Older and/or Intolerable Patients

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: NCT01828619
Recruitment Status : Unknown
Verified April 2013 by FENGRONG WANG, Peking University People's Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 10, 2013
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
FENGRONG WANG, Peking University People's Hospital

Brief Summary:
The purpose of this study is to determine whether the new RIC regimen, containing of low dose of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem cell transplantation.

Condition or disease Intervention/treatment
Leukemia Myelodysplastic Syndrome Procedure: modified BuFlu conditioning

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Study of New RIC Regimen of BuFlu in Older or Intolerable Patients With Hematologic Malignant Diseases
Study Start Date : February 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
modified BuFlu, HSCT, elder/intolerable
The study group is the hematlogic malignant patients that older than 55years and/or with severe concurrent medical conditions, who will undergo HLA-matced allogenic HSCT to cure the disease. The patients will received a modified BuFlu conditioning.
Procedure: modified BuFlu conditioning
The regimen consisted of hydroxyurea 80 mg/kg on d -10; cytorabine 2 g/m2 on d -9; busulfan 3.2mg/kg/day iv. ×3days( on d -8 to -6); Flu30mg/m^2 i.v.×5days(on d-6 to-2) and semustine 250 mg/m2 on d -3.




Primary Outcome Measures :
  1. stem cell engraftment [ Time Frame: 30day post transplantation ]

Secondary Outcome Measures :
  1. toxicity and treatment related mortality [ Time Frame: 100day and 1 year post transplantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population is patients with hematologic malignant diseases, who will undergo HLA matched HSCT.
Criteria

Inclusion Criteria:

  • diagnosed of hematologic malignant disease
  • will undergo HLA matced HSCT
  • age >=55years
  • <55year and intolerable to standard myeloablative conditioning

Exclusion Criteria:

  • KPS status <70
  • cardiac EF<50%
  • creatine clearance <50 ml/min
  • ALT more than 10 times of upper normal limit

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): NCT01828619


Locations
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China
Peking University People's Hospital
Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: XiaoJun Huang, MD Peking University People's Hospital, Department of Hematology
Publications:
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Responsible Party: FENGRONG WANG, Department of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01828619    
Other Study ID Numbers: PKUIH-201303
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013
Keywords provided by FENGRONG WANG, Peking University People's Hospital:
Hematopoietic Stem Cell Transplantation
Busulfan
Fludarabine
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases