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Recruiting NCT05739630

M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

Conditions: Acute Leukemia

Sex: All
Ages: 14 Years – 60 Years
Phase: PHASE2, PHASE3
Enrollment: 60
Sponsor: The First Affiliated Hospital of Soochow University

Location: China

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.

Eligibility Criteria

Inclusion Criteria:The patients meet the diagnostic criteria for acute leukemia(except APL).Expecting life span is more than 3 months.The patients intended allogeneic hematopoietic stem cell transplantation.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:Long QTc syndrome or QTc intervalgt≥480 ms;Complete left bundle branch block, grade II or III Degree atrioventricular block;Severe, uncontrolled arrhythmia requiring drug treatment;New York Society of Cardiology class ≥ II;Cardiac ejection fraction (LVEF) lower than 50% or lower than the study The lower limit of the central laboratory test value range;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.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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05739630). StuddyBuddy aggregates publicly available trial information.