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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03101423
Other study ID # LBo
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date December 31, 2019

Study information

Verified date August 2018
Source First Affiliated Hospital of Guangxi Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hematopoietic stem cell transplantation is currently the only way to cure thalassemia, one of its main obstacles is the rejection after transplantation, chimerism continued to decline, which eventually lead to transplant failure. chimerism is a key indicator of the succession of immune response, which is a key indicator for predicting the failure of hematopoietic stem cell transplantation and provides an important basis for early detection of rejection. Transplantation of continuous chimerism can detect early unstable chimeras and rejection.The chimerism rates after transplantation were continuously monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)

,and then follow our STR different rates for early interventional therapy to prevent further reduction in chimerism leading to lead to graft failure.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Diagnosis of thalassemia major

2. There is no restriction on age or gender.

3. Underwent allogeneic hematopoietic stem cell transplantation, including sibling transplantation, unrelated transplantation and haploidentical transplantation.

4. On +45 day after transplantation, check patients with STR less than 80%.

5. Patients underwent reduce of dosage with a failure treatment by

6. Body condition score (ECOG score) is less than or equal to 1 point who meet follow-up conditions.

Exclusion Criteria:

Complicated with severe cardiac insufficiency and cardiac ejection fraction (EF) was lower than 50%. Complicated with severe pulmonary insufficiency (obstructive and / or restrictive ventilatory disorders). Complicated with severe liver function damage and liver function index (ALT or TBIL) is more than 2 times of the upper limit of the normal value. Complicated with severe renal dysfunction and renal function index (Cr or BUN) is 2 times of the upper limit of the normal value. Complicated with severe active bleeding

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Interleukin-2
On +60 day after transplantation,check patients with STR more than or equal to 90%. transplantat interleukin-2 treatment per month
Donor Regulatory T-Lymphocytes
On +60 day after transplantation,check patients with STR less than 90%. Donor Regulatory T-Lymphocytes infusion (DLI) treatment per month

Locations

Country Name City State
China the First Affiliated Hospital of Guangxi Medical University Nanning Guangxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chimerism after transplantation were monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR) ß thalassemia major patients underwent reduced chimerism rate after allogeneic hematopoietic stem cell transplantation were collected and the chimerism rates after transplantation were continuously monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR).Monitoring once every 20-30 days after allogeneic hematopoietic stem cell transplantation.For patients with reduced chimerism, the results were grouped.We monitor STR-PCR once every 20-30 days after different treatment. Change from chimerism rate at 2-3 months after different treatment
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