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

• ClinicalTrials.gov Identifier: NCT03101423
• Recruitment Status: Unknown
• First Posted: April 5, 2017
• Last Update Posted: August 28, 2018
• Sponsor: First Affiliated Hospital of Guangxi Medical University
• Information provided by (Responsible Party): Liang Bo, First Affiliated Hospital of Guangxi Medical University

Tracking Information

• First Submitted Date: March 26, 2017
• First Posted Date: April 5, 2017
• Last Update Posted Date: August 28, 2018
• Actual Study Start Date: August 1, 2016
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2017)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Beta Thalassemia Major

Intervention

• Drug: Interleukin-2
  On +60 day after transplantation,check patients with STR more than or equal to 90%. transplantat interleukin-2 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

Study Arms

• Active Comparator: interleukin-2
  interleukin-2 treatment per month
  Intervention: Drug: Interleukin-2
• Active Comparator: DLI
  donor lymphocyte infusion (DLI) treatment per month
  Intervention: Drug: Donor Regulatory T-Lymphocytes

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 24, 2018): 30
• Original Estimated Enrollment (submitted: March 30, 2017): 10
• Estimated Study Completion Date: December 31, 2019
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03101423
• Other Study ID Numbers: LBo
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Liang Bo, First Affiliated Hospital of Guangxi Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: First Affiliated Hospital of Guangxi Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: First Affiliated Hospital of Guangxi Medical University
• Verification Date: August 2018