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Status unknownNCT00881933Updated Mar 26, 2012

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

A Phase 1/2 interventional study of Cyclophosphosphamide, TBI in Aplastic Anemia, sponsored by The Korean Society of Pediatric Hematology Oncology. Status unknown at 1 site in South Korea. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2012-03-26.

Sponsored by The Korean Society of Pediatric Hematology Oncology · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
5
Ages
1 Year to 21 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Aplastic Anemia

Keywords

  • Fludarabine, Cyclophosphamide, TBI, severe aplastic anemia,
  • cord blood transplantation, pediatric
03

In context

Anemia, Aplastic

348 studies on the registry are indexed under Anemia, Aplastic; 100 are open to participants now.

This study's planned enrollment of 5 is below the median of 39 across 271 interventional studies indexed under Anemia, Aplastic.

Browse Anemia, Aplastic studies →

Lead sponsor

The Korean Society of Pediatric Hematology Oncology is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Fludarabine

    Other: Cyclophosphosphamide, TBI

Interventions

  • OtherCyclophosphosphamide, 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)

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate the incidence and severity of toxicity and treatment related mortality

    Time frame: From Oct 2008. to Sep 2011

  2. To evaluate overall and event free survival rate

    Time frame: From Oct 2008. to Sep 2011

  3. To evaluate acute and chronic GVHD

    Time frame: From Oct 2008. to Sep 2011

  4. To evaluate immunologic recovery after CBT

    Time frame: From Oct 2008. to Sep 2011

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 110-744, South Korea
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2008, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2009
First posted
Apr 15, 2009
Start
Nov 2008
Primary completionEst.
Sep 2012
CompletionEst.
Sep 2012
Last update
Mar 26, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00881933
Lead sponsor
The Korean Society of Pediatric Hematology Oncology
First posted
Apr 15, 2009
Start date
Nov 2008
Primary completion
Sep 2012 (estimated)
Completion
Sep 2012 (estimated)
Last update
Mar 26, 2012

Study contacts

Hyoung Jin Kang, M.D, Ph.D
Contact
kanghj@snu.ac.kr
82 2 2072 3304
Ji Won Lee, M.D
Contact
agnesjw@hanmail.net
82 2 2072 0177
Hyo Seop Ahn, M.D, Ph.D
principal investigator · The Korean Society of Pediatric Hematology Oncology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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