M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

Phase 2

Recruiting

• Conditions: Acute Leukemia
• Interventions: Drug: mitoxantrone liposome; Drug: ATG

• Registration Number: NCT05739630
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Primary Completion: 2024-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M+PTCy group	mitoxantrone liposome	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.
BuCy group	ATG	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From the 1st day to 2 years after enrollment	It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	From the 1st day to 2 years after enrollment	The time from randomization to death from any cause.
CMV and EBV activation	From the 1st day to 2 years after enrollment	The incidencance of cytomegalovirus and Epstein-barr virus infection
incidence of GVHD	From the 1st day to 2 years after enrollment	The incidence of graft-versus-host disease

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China