M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

An Multicenter, Randomized, Controlled, Prospective Clinical Study of Mitoxantrone Liposome Combined With PTCy as Conditioning Regimen in Allo-HSCT in Acute Leukemia

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.

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.

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.