This study intends to evaluate the efficiency and safety of M-PTCy as conditioningregimen in Haploidentical HSCT for Acute Leukemia, so as to provide a new conditioningregimen for allogeneic hematopoietic cell transplantation.
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.
Drug: mitoxantrone liposome
Mitoxantrone liposomes with 36mg/m2 and Bu 3.2mg/kg -5 to -4, Flu 30mg/m2 -12 to -9,
Ara-C 1.5g/m2 -12 to -9，CTX 15mg/kg/d -3 to -2, was used as conditioning regimen, Post
Transplant Cyclophosphamide 50 mg/kg IV daily on days +3 and +4.
Other Name: Fludarabine,Cytarabine,busulfan,Cyclophosphamide,MMF,Tacrolimus Capsules
Drug: ATG
Control group:the conditioning regimen involved Ara-C 2g/m2 q12h -8, BU 3.2 mg/kg -7 to
-5,CTX 1.8 g/m2 -4 to -3, to prevent GVHD, MTX 15mg/m2 +1d, 10mg/m2 +3,+6,+11,CsA
3mg/kg/d from -8d,MMF 1g q12h from -8d， ATG 2.5mg/kg/d -5 to -2.
Other Name: MECCNU,Hu,Cytarabine,busulfan,Cyclophosphamide,MTX,CsA
Inclusion Criteria:
1. The patients meet the diagnostic criteria for acute leukemia(except APL).
2. Expecting life span is more than 3 months.
3. The patients intended allogeneic hematopoietic stem cell transplantation.
Exclusion Criteria:
1. Previously received doxorubicin or other anthracycline therapy, the total cumulative
dose of doxorubicin≥360 mg/m2.
2. Cardiac function and disease meet one of the following conditions:
1. Long QTc syndrome or QTc intervalgt≥480 ms;
2. Complete left bundle branch block, grade II or III Degree atrioventricular
block;
3. Severe, uncontrolled arrhythmia requiring drug treatment;
4. New York Society of Cardiology class ≥ II;
5. Cardiac ejection fraction (LVEF) lower than 50% or lower than the study The
lower limit of the central laboratory test value range;
6. History of myocardial infarction, unstable angina, severe unstable ventricular
arrhythmia or any other arrhythmia requiring treatment, clinically serious
pericardial disease history within 6 months before recruitment, or ECG evidence
of acute ischemia or active conduction system abnormalities.
3. 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.
4. Suffering from other malignant tumors in the past or at the same time ;
5. Exclude patients with severe active infection or other underlying diseases who
cannot tolerate chemotherapy;
6. Human immunodeficiency virus (HIV) infected patients (HIV antibody positive);
7. Active hepatitis B and C infection；
8. Pregnant women, lactating women, and patients who refuse to take effective
contraceptive measures during the study;
9. Severe mental disorders who do not cooperate with treatment;
10. Judgment by the investigator , There are patients who are not suitable to
participate in this study.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Investigator: Yue Han
Contact: +86 13901551669
hanyuesz@163.com
Ruju Wang, MD
13912629420
wrja0515@163.com
Huizhu Kang, MD
8761925608
khz11826@sina.com
Yue Han, MD/phD, Principal Investigator
Study Principle investigator