HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors

HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3 Depletion for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors After Conditioning of TBI, Fludarabine, Cyclophosphamide and Antithymocyte Globulin

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01509300

Enrollment

Registered

2012-01-13

Start date

2012-01-31

Completion date

2014-03-31

Last updated

2012-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Myelodysplastic Syndrome, Solid Tumors

Keywords

TBI, Fludarabine, CD3 depletion, Children and adolescents, Haploidentical hematopoietic stem cell transplantation

Brief summary

RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, T-cell depletion may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation. PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine, cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical donors in treating patients with acute leukemia and myelodysplastic syndrome.

Interventions

BIOLOGICALanti-thymocyte globulin

On days -10 to -9

BIOLOGICALfilgrastim

Beginning on day 4 and continuing until blood counts recover

RADIATIONTotal body irradiation

2Gy D-6 to D-4

DRUGFludarabine

30mg/M2 once daily IV on days -8 to -4

DRUGcyclophosphamide

60 mg/kg IV on day-3 and -2

DRUGTacrolimus

begin on 0

DRUGMycophenolate mofetil

begin on 0

DRUGRituximab

375mg/m2 on day +21

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

Healthy volunteers

Inclusion criteria

1. Disease characteristics * Acute lymphoblastic leukemia (first remission, high risk; beyond first remission; refractory) * Acute myeloblastic leukemia (first remission, high risk; beyond first remission; refractory) * Myelodysplastic syndrome * Solid tumors (Refractory/relapse) 2. No HLA-identical family member or closely matched (8 or 7 of 8 HLA-locus match) unrelated marrow donor available 3. HLA-haploidentical related donor available

Exclusion criteria

1. Active fungal infections 2. HIV positive 3. Pregnant or nursing

Design outcomes

Primary

Measure	Time frame
Transplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells.	2 years post-transplant

Secondary

Measure	Time frame	Description
Engraftment and graft failure rates	28 days engraftment and graft failure	Number of patients who failed to stable engraftment by 28 days
Incidence of acute GVHD	100 days post-transplant	Number of patients with acute GVHD.
Treatment related mortality	100 days post-transplant	Number of death after transplantation
Relapse rate and overall survival	2 year after transplantation	—

Countries

South Korea

Contacts

Primary ContactHo Joon Im, MD & PhD

hojim@amc.seoul.kr82-2-3010-3371

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026