Last updated: February 19, 2023
Sponsor: Yi Luo
Overall Status: Active - Recruiting
Phase
2
Condition
Leukemia
Treatment
N/AClinical Study ID
NCT04688021
TZ-001
Ages 16-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with hematological malignancies in complete remission (CR) who are eligibleand planned for haploidentical HSCT. The donor specific antibody is negative
- Patient age 16-60 years
- Mother donor, or female donor (age >50) for female-male transplant
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Creatinine clearance rate > 60 mL/min (estimate by Cockcroft-Gault Equation)
- alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 2.5×upper limit ofnormal (ULN), and total bilirubin ≤ 1.5×ULN (upper limit of normal, ULN)
- Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography
- Acceptation to sign the informed consent
Exclusion
Exclusion Criteria:
- History of previous HSCT
- Present active infection (including bacterial, virus or fungal)
- History of Tocilizumab infection
- History of inflammatory bowel disease
- History of demyelinating disease
- Patients who are HIV-positive, or with uncontrolled chronic hepatitis B virus (HBsAgpositive) or hepatitis C virus (anti-HCV) infections
- Women who are pregnant (β-chorionic gonadotropin+) or breast feeding
- Refusal to sign the informed consent
Study Design
Total Participants: 46
Study Start date:
December 03, 2020
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou,
ChinaActive - Recruiting
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