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Status unknownNCT03101423Updated Aug 28, 2018

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

An interventional study of Interleukin-2 and Donor Regulatory T-Lymphocytes in Beta Thalassemia Major, sponsored by First Affiliated Hospital of Guangxi Medical University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-08-28.

Sponsored by First Affiliated Hospital of Guangxi Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Aug 2016, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Sex
All
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Study 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.

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Conditions studied

  • Beta Thalassemia Major

Keywords

  • thalassemia
  • transplantation
  • chimerism
  • donor ymphocytes
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In context

Thalassemia

416 studies on the registry are indexed under Thalassemia; 67 are open to participants now.

This study's planned enrollment of 30 is below the median of 37 across 277 interventional studies indexed under Thalassemia.

Browse Thalassemia studies →

Lead sponsor

First Affiliated Hospital of Guangxi Medical University is the lead sponsor of 41 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    interleukin-2

    interleukin-2 treatment per month

    Drug: Interleukin-2

  • Active comparator
    DLI

    donor lymphocyte infusion (DLI) treatment per month

    Drug: Donor Regulatory T-Lymphocytes

Interventions

  • DrugInterleukin-2

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

  • DrugDonor Regulatory T-Lymphocytes

    On +60 day after transplantation,check patients with STR less than 90%. Donor Regulatory T-Lymphocytes infusion (DLI) treatment per month

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from chimerism rate at 2-3 months after different treatment

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Study locations

1 site
  • the First Affiliated Hospital of Guangxi Medical University
    Nanning, Guangxi 530021, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03101423
Lead sponsor
First Affiliated Hospital of Guangxi Medical University
Responsible party
Liang Bo (Principal Investigator, First Affiliated Hospital of Guangxi Medical University) — Principal investigator
First posted
Apr 5, 2017
Start date
Aug 1, 2016
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Aug 28, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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