Clinical trial · Interventional
Study of Reduced Toxicity Myeloablative Conditioning Regimen for Cord Blood Transplantation in Pediatric AML
Phase II Study of Reduced Toxicity Myeloablative Conditioning Regimen for Cord Blood Transplantation in Pediatric Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 transplantation with lower graft versus host disease (GVHD) severity and incidence, transplantation related mortality (TRM) has been major problems after myeloablative conditioning. To reduce TRM, CBT with non-myeloablative conditionings have been performed but not so satisfactory especially for engraftment rate. Recently reduced toxicity myeloablative conditioning regimen was developed with promising result in adult bone marrow or mobilized peripheral blood transplantation. To increase the engraftment potential with low TRM rate, reduced toxicity myeloablative conditioning composed of fludarabine, intravenous busulfan plus thymoglobulin is planned for pediatric patients with acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine, Busulfan, Thymoglobulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludarabine
- interventionNames
- Drug: Fludarabine, Busulfan, Thymoglobulin
Primary outcomes (2)
- measure
- To evaluate the engraftment potential of fludarabine, busulfan plus thymoglobulin conditioning regimen for CBT in AML.
- timeFrame
- From June 2006 to May 2010
- measure
- To evaluate the incidence and severity of toxicity and treatment related mortality.
- timeFrame
- From June 2006 to May 2010
Secondary outcomes (3)
- measure
- To evaluate overall and event free survival rate.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of acute myeloid leukemia (FAB or WHO classification). 2. Indicated for hematopoietic stem cell transplantation. 3. Age: \< 21 years old. 4. Performance status: ECOG 0-2. 5. 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. 6. Patients must lack any active viral infections or active fungal infection. 7. 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. 8. One of parents should sign informed consent. Exclusion Criteria: 1. Pregnant or nursing women. 2. Malignant (except acute myeloid leukemia) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 3. Psychiatric disorder that would preclude compliance. 4. More than three HLA type mismatch. 5. T cell depleted or ex vivo expanded cord blood.
References
Publications (0)
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