Status:
UNKNOWN
Study of Reduced Toxicity Myeloablative Conditioning Regimen for Cord Blood Transplantation in Pediatric AML
Lead Sponsor:
The Korean Society of Pediatric Hematology Oncology
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
PHASE2
Brief Summary
Cord blood transplantation (CBT) is an alternative option for patients with pediatric acute leukemia that indicated stem cell transplantation. Although CBT is as affective as unrelated bone marrow tra...
Detailed Description
Since the first successful transplantation using umbilical cord blood (UCB) to treat a patient with Fanconi anemia in 1988 (Gluckman E, 1989), cord blood transplantation (CBT) has become an alternativ...
Eligibility Criteria
Inclusion
- Diagnosis of acute myeloid leukemia (FAB or WHO classification).
- Indicated for hematopoietic stem cell transplantation.
- Age: \< 21 years old.
- 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. 1. Heart: a shortening fraction \> 30%, ejection fraction \> 45%. 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. 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.
- Appropriate cord blood unit is available: accept HLA mismatch in two of six loci (pairs of A, B, and DR). Allow 2 units cord transplantation.
- One of parents should sign informed consent.
Exclusion
- Pregnant or nursing women.
- Malignant (except acute myeloid leukemia) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
- Psychiatric disorder that would preclude compliance.
- More than three HLA type mismatch.
- T cell depleted or ex vivo expanded cord blood.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00887042
Start Date
June 1 2006
End Date
May 1 2012
Last Update
March 26 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, Chongno-gu, South Korea, 110-744