Clinical trial NCT05739630: M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia
Official title: An Multicenter, Randomized, Controlled, Prospective Clinical Study of Mitoxantrone Liposome Combined With PTCy as Conditioning Regimen in Allo-HSCT in Acute Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Leukemia
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From the 1st day to 2 years after enrollment
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: From the 1st day to 2 years after enrollment
measure: incidence of GVHD
timeFrame: From the 1st day to 2 years after enrollment
measure: CMV and EBV activation
timeFrame: From the 1st day to 2 years after enrollment
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Study Principle investigator
name: Yue Han, MD/phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Apperley J, Niederwieser D, Huang XJ, Nagler A, Fuchs E, Szer J, Kodera Y. Reprint of: Haploidentical Hematopoietic Stem Cell Transplantation: A Global Overview Comparing Asia, the European Union, and the United States. Biol Blood Marrow Transplant. 2016 Mar;22(3 Suppl):S15-8. doi: 10.1016/j.bbmt.2016.01.006.