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

Sponsor

First Affiliated Hospital of Guangxi Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03101423

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Beta Thalassemia Major	Drug: Interleukin-2 Drug: Donor Regulatory T-Lymphocytes	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: interleukin-2 interleukin-2 treatment per month	Drug: Interleukin-2 On +60 day after transplantation,check patients with STR more than or equal to 90%. transplantat interleukin-2 treatment per month
Active Comparator: DLI donor lymphocyte infusion (DLI) treatment per month	Drug: 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

Arm

Intervention/Treatment

Active Comparator: interleukin-2

interleukin-2 treatment per month

Drug: Interleukin-2

On +60 day after transplantation,check patients with STR more than or equal to 90%. transplantat interleukin-2 treatment per month

Active Comparator: DLI

donor lymphocyte infusion (DLI) treatment per month

Drug: 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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of thalassemia major
There is no restriction on age or gender.
Underwent allogeneic hematopoietic stem cell transplantation, including sibling transplantation, unrelated transplantation and haploidentical transplantation.
On +45 day after transplantation, check patients with STR less than 80%.
Patients underwent reduce of dosage with a failure treatment by
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