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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03101423
Recruitment Status : Unknown
Verified August 2018 by Liang Bo, First Affiliated Hospital of Guangxi Medical University.
Recruitment status was:  Active, not recruiting
First Posted : April 5, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Liang Bo, First Affiliated Hospital of Guangxi Medical University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Chimerism after transplantation were monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR) [ Time Frame: 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
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101423


Locations
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China, Guangxi
the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Sponsors and Collaborators
First Affiliated Hospital of Guangxi Medical University
More Information
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Responsible Party: Liang Bo, Principal Investigator, First Affiliated Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT03101423    
Other Study ID Numbers: LBo
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liang Bo, First Affiliated Hospital of Guangxi Medical University:
thalassemia
transplantation
chimerism
donor ymphocytes
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
 Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs