M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

Acute Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739630
• Other study ID #: 2023003
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2023
• Source: The First Affiliated Hospital of Soochow University
• Contact: Ruju Wang, MD
• Phone: 13912629420
• Email: wrja0515[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause.	From the 1st day to 2 years after enrollment
Secondary	Overall survival (OS)	The time from randomization to death from any cause.	From the 1st day to 2 years after enrollment
Secondary	incidence of GVHD	The incidence of graft-versus-host disease	From the 1st day to 2 years after enrollment
Secondary	CMV and EBV activation	The incidencance of cytomegalovirus and Epstein-barr virus infection	From the 1st day to 2 years after enrollment