Clinical trial
Impact of Optimal Doses of Antithymocyte Globulin Conditioning on Graft-versus- Host Disease and Virus Reactivation in Haploidentical Hematopoietic Stem Cell Transplantation
Name
S2020-484-01
Description
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 peripheral blood stem cell transplantation (haplo-PBSCT).
Trial arms
Trial start
2020-12-01
Estimated PCD
2022-07-31
Trial end
2024-01-14
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Antithymocyte Globulin
Individual dose of ATG was Intravenous infused every day from day -5 to day -2 (total ATG dose was calculated based on pharmacokinetic index, within a range of 6 mg/kg to 10mg/kg). Antithymocyte globulin (ATG) was added to conditioning regimens for 4 days (days -5 and -2). Prophylaxis against graft-versus-host disease (GVHD) was performed with cyclosporine A (CsA), mycophenolate mofetil (MMF) and short-term methotrexate
Arms:
Individual dose of Thymoglobulin
Size
63
Primary endpoint
The cumulative incidences of CMV reactivation
180 days after transplantation
The cumulative incidences of EBV reactivation
180 days after transplantation
Eligibility criteria
Inclusion Criteria:
1. Confirmed diagnosis of hematological malignancies refer to the 2016 WHO classification.
2. Aged 14 to 60 years.
3. Karnofsky or Lansky performance status \[27\] ≥ 70%. Please refer to Appendix A.
4. First transplantation.
5. Adequate organ function
6. Patient and/or legal guardian must sign informed consent for HSCT.
Exclusion Criteria:
1. Ex-vivo T-cell depleted grafts.
2. Pregnancy or breast-feeding or unwilling to use proper contraception.
3. Unable to assess whether the malignancy is in complete remission.
4. History of hypersensitivity to any biological product.
5. Sensibility to rabbit proteins or previous treatment with Thymoglobuline®.
6. Subjects with uncontrollable systemic infection (viral, bacterial or fungal).
7. Participation in other trial in which the dose of Thymoglobuline® is fixed other than individualized dose.
8. Unable to sign the informed consent form.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 63, 'type': 'ESTIMATED'}}
Updated at
2023-04-11
1 organization
1 product
1 indication
Organization
Chinese PLA General HospitalProduct
Antithymocyte Globulin