Overview

Efficacy of Basiliximab in the Prevention of Acute Graft-versus-host Disease in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Therapy for Thalassemia Major

Status:
Unknown status

Trial end date:
2018-12-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate the basiliximab for prevention of graft-versus-host disease in unrelated allo-genetic hematopoietic stem cell transplantation for thalassemia major. The objective was to evaluate the effect and safety of basiliximab for acute graft-versus-host disease.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Affiliated hospital of guangxi medical university,china

Collaborators:

Kunming general Hospital of Chengdu Military Region
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Union hospital of Fujian Medical University
Zhongshan Hospital Xiamen University

Treatments:

Antibodies, Monoclonal
Basiliximab
Cyclosporine
Cyclosporins
Methotrexate
Mycophenolate mofetil
Mycophenolic Acid

Criteria

Inclusion Criteria:

1. Age: 2 to 18 years old

2. Gender: Male or female

3. Thalassemia major

4. Donor and recipient sides 10/10 consistency

5. Unrelated allogeneic peripheral blood stem cell transplantation

6. In good general condition , ECOG score ≤ 1

7. Normal heart function: ejection fraction ≥ 50%

8. Normal liver and renal function: Serum bilirubin ≤ 35μmol / L, AST / ALT less than 2
times the upper limit , serum creatinine under 2 times the upper limit

9. Enrolled subjects or their families signed informed consent

Exclusion Criteria:

1. severe infection uncontrolled before transplantation

2. severe allergic on Basiliximab (anaphylactic shock or laryngeal edema)

3. sibling allogeneic hematopoietic stem cell transplantation

4. Cardiac dysfunction (ejection fraction <50%)

5. Renal insufficiency (serum creatinine> 130umol / L)

6. Hepatic dysfunction (total bilirubin> 34umol / L, ALT, AST> 2 times the upper limit of
normal)

7. Previously history of allogeneic hematopoietic stem cell transplantation

8. Other circumstances which do not meet the inclusion criteria