Status:
UNKNOWN
Individualized Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Haploidentical Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
14-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the response and toxicity rate of two different dosages (Individualized dosage VS. fixed dosage) of ATG as a prophylaxis for acute GVHD in haploidentical peri...
Detailed Description
Acute graft-versus-host disease (aGvHD) is an important complication of haplo-HSCT. The Seattle group initially introduced the use of ATG as a treatment for acute graft-versus-host disease (aGVHD) in ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of hematological malignancies refer to the 2016 WHO classification.
- Aged 14 to 60 years.
- Karnofsky or Lansky performance status \[27\] ≥ 70%. Please refer to Appendix A.
- First transplantation.
- Adequate organ function
- Patient and/or legal guardian must sign informed consent for HSCT.
Exclusion
- Ex-vivo T-cell depleted grafts.
- Pregnancy or breast-feeding or unwilling to use proper contraception.
- Unable to assess whether the malignancy is in complete remission.
- History of hypersensitivity to any biological product.
- Sensibility to rabbit proteins or previous treatment with Thymoglobuline®.
- Subjects with uncontrollable systemic infection (viral, bacterial or fungal).
- Participation in other trial in which the dose of Thymoglobuline® is fixed other than individualized dose.
- Unable to sign the informed consent form.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 14 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04778618
Start Date
December 1 2020
End Date
January 14 2024
Last Update
April 11 2023
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853