Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Chimerism after transplantation were monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
interleukin-2
interleukin-2 treatment per month
干预措施: Interleukin-2 (Drug)
DLI
donor lymphocyte infusion (DLI) treatment per month
干预措施: Donor Regulatory T-Lymphocytes (Drug)
结局指标
主要结局
Chimerism after transplantation were monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)
时间窗: 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.
次要结局
未报告次要终点
研究者
Liang Bo
Principal Investigator
First Affiliated Hospital of Guangxi Medical University