Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism

Not Applicable

• Conditions: Beta Thalassemia Major
• Interventions: Drug: Donor Regulatory T-Lymphocytes; Drug: Interleukin-2

• Registration Number: NCT03101423
• Lead Sponsor: First Affiliated Hospital of Guangxi Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-28
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DLI	Donor Regulatory T-Lymphocytes	donor lymphocyte infusion (DLI) treatment per month
interleukin-2	Interleukin-2	interleukin-2 treatment per month

Primary Outcome Measures

Name	Time	Method
Chimerism after transplantation were monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)	Change from chimerism rate at 2-3 months after different treatment	β 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.

Trial Locations

Locations (1)

the First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China