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M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

S

Soochow University

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Acute Leukemia

Treatments

Drug: mitoxantrone liposome
Drug: ATG

Study type

Interventional

Funder types

Other

Identifiers

NCT05739630
2023003

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

14 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

M+PTCy group
Experimental group
Description:
For the M-PTCy group, 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.
Treatment:
Drug: mitoxantrone liposome
BuCy group
Active Comparator group
Description:
For the BUCY 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.
Treatment:
Drug: ATG

Trial contacts and locations

1

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Central trial contact

Huizhu Kang, MD; Ruju Wang, MD

Data sourced from clinicaltrials.gov

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