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

August 24, 2018 updated by: Liang Bo, First Affiliated Hospital of Guangxi Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from chimerism rate at 2-3 months after different treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

March 26, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (ACTUAL)

April 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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