Back to resultsMonitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism
Primary Purpose
Beta Thalassemia Major
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Interleukin-2
Donor Regulatory T-Lymphocytes
Sponsored by
About this trial
This is an interventional treatment trial for Beta Thalassemia Major focused on measuring thalassemia, transplantation, chimerism, donor ymphocytes
Eligibility Criteria
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
Sites / Locations
- the First Affiliated Hospital of Guangxi Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
interleukin-2
DLI
Arm Description
interleukin-2 treatment per month
donor lymphocyte infusion (DLI) treatment per month
Outcomes
Primary Outcome Measures
Chimerism after transplantation were monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03101423
First Posted
March 26, 2017
Last Updated
August 24, 2018
Sponsor
First Affiliated Hospital of Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03101423
Brief Title
Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism
Official Title
Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Guangxi Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Beta Thalassemia Major
Keywords
thalassemia, transplantation, chimerism, donor ymphocytes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interleukin-2
Arm Type
Active Comparator
Arm Description
interleukin-2 treatment per month
Arm Title
DLI
Arm Type
Active Comparator
Arm Description
donor lymphocyte infusion (DLI) treatment per month
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Intervention Description
On +60 day after transplantation,check patients with STR more than or equal to 90%. transplantat interleukin-2 treatment per month
Intervention Type
Drug
Intervention Name(s)
Donor Regulatory T-Lymphocytes
Intervention Description
On +60 day after transplantation,check patients with STR less than 90%. Donor Regulatory T-Lymphocytes infusion (DLI) treatment per month
Primary Outcome Measure Information:
Title
Chimerism after transplantation were monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)
Description
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.
Time Frame
Change from chimerism rate at 2-3 months after different treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
the First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
12. IPD Sharing Statement
Learn more about this trial
Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism
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