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Study of Fludarabine + Cyclophosphamide + TBI Conditioning Regimen for Double Units Cord Blood Transplantation(CBT)in Severe Aplastic Anemia(SAA)

This study is currently recruiting participants.
Verified March 2012 by The Korean Society of Pediatric Hematology Oncology
Sponsor:
Information provided by:
The Korean Society of Pediatric Hematology Oncology
ClinicalTrials.gov Identifier:
NCT00881933
First received: April 14, 2009
Last updated: March 23, 2012
Last verified: March 2012
History of Changes

April 14, 2009
March 23, 2012
November 2008
September 2012   (final data collection date for primary outcome measure)
To evaluate the engraftment potential of fludarabine, busulfan plus thymoglobulin conditioning regimen for cord blood transplantation (CBT) in severe aplastic anemia. [ Time Frame: From Oct 2008. to Sep 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881933 on ClinicalTrials.gov Archive Site
  • To evaluate the incidence and severity of toxicity and treatment related mortality [ Time Frame: From Oct 2008. to Sep 2011 ] [ Designated as safety issue: No ]
  • To evaluate overall and event free survival rate [ Time Frame: From Oct 2008. to Sep 2011 ] [ Designated as safety issue: No ]
  • To evaluate acute and chronic GVHD [ Time Frame: From Oct 2008. to Sep 2011 ] [ Designated as safety issue: No ]
  • To evaluate immunologic recovery after CBT [ Time Frame: From Oct 2008. to Sep 2011 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Fludarabine + Cyclophosphamide + TBI Conditioning Regimen for Double Units Cord Blood Transplantation(CBT)in Severe Aplastic Anemia(SAA)
Phase I/II Study of Fludarabine, Cyclophosphamide Plus TBI Conditioning Regimen for Double Units Cord Blood Transplantation in Severe Aplastic Anemia

Severe aplastic anemia is a fatal disease and patients without HLA matched siblings need alternative treatment option. Cord blood transplantation (CBT) has become an alternative treatment means in various diseases, but it has not been proved to be good for severe aplastic anemia. Double units CBT is proposed to have better engraftment potential and and we reported successful double units UCBT after engraftment failure with single unit with promising result. To increase the engraftment potential, fludarabine, cyclophosphamide plus TBI conditioning regimen for double units cord blood transplantation was proposed for the patient with severe aplastic anemia without HLA-matched donor.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Aplastic Anemia
Other: Cyclophosphosphamide, TBI
fludarabine (30 mg/m2 once daily i.v. on days -7, -6, -5, -4, -3, & -2) (if body weight < 10 kg or if age < 1 year: 1.33 mg/kg) cyclophosphamide (60 mg/kg once daily i.v. on days -9, & -8) total body irradiation (3G on days -1)
Experimental: Fludarabine
Intervention: Other: Cyclophosphosphamide, TBI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria and either marrow criterion.

  • Peripheral blood

    • Neutrophils < 0.5 x 109/l
    • Platelets < 20 x 109/l
    • Corrected reticulocytes < 1%

  • Bone marrow

    • Severe hypocellularity (< 25%)
    • Moderate hypocellularity (25-30%) with hematopoietic cells representing < 30% of residual cells
  • No prior hematopoietic stem cell transplantation.
  • Age: no limits.
  • Performance status: ECOG 0-2.

  • Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.

    • Heart: a shortening fraction > 30%, ejection fraction > 45%.
    • Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal.
    • Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.
  • Patients must lack any active viral infections or active fungal infection.
  • No appropriate donor
  • Appropriate cord blood is available: matched at least in 4/6 of A, B, DR loci.
  • Patients (or one of parents if patients age < 19) should sign informed consent.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
  • Psychiatric disorder that would preclude compliance.
  • Congenital aplastic anemia including Fanconi anemia.
Both
1 Year to 21 Years
No
Contact: Hyoung Jin Kang, M.D, Ph.D 82 2 2072 3304 kanghj@snu.ac.kr
Contact: Ji Won Lee, M.D 82 2 2072 0177 agnesjw@hanmail.net
Korea, Republic of
 
NCT00881933
KSPHO-SCT0804
Yes
The Korean Society of Hematology, The Korean Society of Pediatric Hematology Oncology
The Korean Society of Pediatric Hematology Oncology
Not Provided
Principal Investigator: Hyo Seop Ahn, M.D, Ph.D The Korean Society of Pediatric Hematology Oncology
The Korean Society of Pediatric Hematology Oncology
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP