Unrelated Umbilical Cord Blood Following HLA-haploidentical Hematopoietic Stem Cell Transplantation in Patients With β-thalassemia Major

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02126046

Enrollment

Registered

2014-04-29

Start date

2012-09-30

Completion date

2016-03-31

Last updated

2015-04-16

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

Conditions

Thalassemia Major

Keywords

Cord Blood Transplant, Haploidentical HSCT, Thalassemia major

Brief summary

Allo-hematopoietic stem cell transplantation(HSCT) is the only way to cure β-thalassemia major at present. To expand donor pool，we developed a haplo-identical HSCT (Hi-HSCT) platform. But in prior Hi-HSCT using high dose post-transplant Cyclophosphamide in patients with leukemia, cytopenia post-transplant often developed, which was considered as a symptom of GVHD. Therefore, the investigators add unrelated umbilical cord blood (UCB) to the Hi-HSCT. It has reported that, as third-party cells, UCB will reduce GVHD.The purpose of this study is to determine whether unrelated UCB following Hi-HSCT can improve outcomes of Hi-HSCT in patients with β-thalassemia major.

Interventions

GENETICunrelated CB following haplo-identical hematopoietic stem cells transplantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 18 Years

Healthy volunteers

Inclusion criteria

* β-thalassemia major * \< 18 year old * Unrelated umbilical cord blood following Haplo-identical HSCT

Exclusion criteria

* ≥ 18 year old * HLA- matched related donors * Unrelated donor transplants * Unrelated umbilical cord blood transplants * Severe iron overload in heart by T2\*

Design outcomes

Primary

Measure	Time frame	Description
overall survival（OS）	12 months	the measure is a composite
TM-free survival（TFS）	12 months	the measure is a composite
Transplant Related Martality (TRM)	12 months	the measure is a composite
Primary or Secondary Graft Rejection (GR)	12 months	the measure is a composite

Secondary

Measure	Time frame	Description
The cumulative incidences of acute graft-versus-host disease（GVHD）	12 months	the measure is a composite
The cumulative incidences of chronic graft vesus host disease (cGVHD)	12 months	the measure is a composite

Countries

China

Contacts

Primary ContactChunfu Li, professor

chunfugzcn@126.com+86 20 61641921

Backup ContactZhiyong Peng, Doctor

pengzhiyong8@163.com+86 20 61641925

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026