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This study intends to evaluate the efficiency and safety of M-PTCy as conditioning regimen in Haploidentical HSCT for Acute Leukemia, so as to provide a new conditioning regimen for allogeneic hematopoietic cell transplantation.
Full description
Haploidentical related donor transplantation is now considered an important alternative to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Posttransplant cyclophosphamide (PTCy) has revolutionized Haplo HCT with acceptable rates of engraftment, graft-versus-host disease (GVHD), relapse, and survival.To prolonger PFS, OS and alleviate GVHD, we combined Mitoxantrone liposomes with PTCy as conditioning regimen in allogeneic hematopoietic cell transplantation.
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Inclusion criteria
Exclusion criteria
Previously received doxorubicin or other anthracycline therapy, the total cumulative dose of doxorubicin≥360 mg/m2.
Cardiac function and disease meet one of the following conditions:
Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN); Total bilirubin > 1.5 times upper limit of normal; Serum creatinine > 1.5 times the upper limit of normal.
Suffering from other malignant tumors in the past or at the same time ;
Exclude patients with severe active infection or other underlying diseases who cannot tolerate chemotherapy;
Human immunodeficiency virus (HIV) infected patients (HIV antibody positive);
Active hepatitis B and C infection;
Pregnant women, lactating women, and patients who refuse to take effective contraceptive measures during the study;
Severe mental disorders who do not cooperate with treatment;
Judgment by the investigator , There are patients who are not suitable to participate in this study.
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Central trial contact
Ruju Wang, MD; Huizhu Kang, MD
Data sourced from clinicaltrials.gov
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