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Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescents

NCT02014506 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-03-28

No results posted yet for this study

Summary

Purpose of study: This phase I/II trial is to evaluate the safety and feasibility of TCRαβ-depleted graft from haploidentical family donors in treating children and adolescents with malignant or non-malignant diseases.

Conditions

  • Haploidentical Hematopoietic Stem Cell Transplantation
  • Malignant Disease
  • Non-malignant Disease

Interventions

DRUG

Fludarabine

40mg/M2 once daily IV on days -7 to -2

DRUG

Cyclophosphamide

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

BIOLOGICAL

anti-thymocyte globulin

BIOLOGICAL

filgrastim

Beginning on day 4 and continuing until blood counts recover

RADIATION

Total body irradiation

200 cGy per day on D-6 to -4 (eligible disease except aplastic anemia) 200 cGy per day on D-5 \& -4 (severe aplastic anemia)

PROCEDURE

TCRαβ-depleted hematopoietic cell transplantation

DEVICE

CliniMACS

Immunogenetic depletion of TCRαβ cells

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Ho Joon Im, MD, PhD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02014506 on ClinicalTrials.gov