NCT00887042

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

5.9 years

First QC Date

April 21, 2009

Last Update Submit

March 23, 2012

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemiaCord blood transplantationPediatric

Outcome Measures

Primary Outcomes (2)

  • To evaluate the engraftment potential of fludarabine, busulfan plus thymoglobulin conditioning regimen for CBT in AML.

    From June 2006 to May 2010

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

    From June 2006 to May 2010

Secondary Outcomes (3)

  • To evaluate overall and event free survival rate.

    From June 2006 to May 2010

  • To evaluate acute and chronic GVHD.

    From June 2006 to May 2010

  • To evaluate immunologic recovery after CBT.

    From June 2006 to May 2010

Study Arms (1)

Fludarabine

EXPERIMENTAL
Drug: Fludarabine, Busulfan, Thymoglobulin

Interventions

Fludarabine, Busulfan, ThymoglobulinDRUG

fludarabine (40 mg/m2 once daily i.v. on days -8, -7, -6, -5, -4 \& -3) busulfan (0.8 mg/kg every 6 hours i.v. on days -6, -5, -4, \& -3) thymoglobulin (2.5 mg/kg once daily i.v. on days -8, -7, \& -6)

Fludarabine

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Chongno-gu, 110-744, South Korea

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

fludarabineBusulfanthymoglobulin

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Hyo Seop Ahn, M.D, Ph. D

    The Korean Society of Pediatric Hematology Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

June 1, 2006

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

KR(1)