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M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

Primary Purpose

Acute Leukemia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
mitoxantrone liposome
ATG
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

M+PTCy group

BuCy group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival (OS)
The time from randomization to death from any cause.
incidence of GVHD
The incidence of graft-versus-host disease
CMV and EBV activation
The incidencance of cytomegalovirus and Epstein-barr virus infection

Full Information

First Posted
February 13, 2023
Last Updated
February 13, 2023
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05739630
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M+PTCy group
Arm Type
Experimental
Arm 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.
Arm Title
BuCy group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
mitoxantrone liposome
Other Intervention Name(s)
Fludarabine,Cytarabine,busulfan,Cyclophosphamide,MMF,Tacrolimus Capsules
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ATG
Other Intervention Name(s)
MECCNU,Hu,Cytarabine,busulfan,Cyclophosphamide,MTX,CsA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause.
Time Frame
From the 1st day to 2 years after enrollment
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
The time from randomization to death from any cause.
Time Frame
From the 1st day to 2 years after enrollment
Title
incidence of GVHD
Description
The incidence of graft-versus-host disease
Time Frame
From the 1st day to 2 years after enrollment
Title
CMV and EBV activation
Description
The incidencance of cytomegalovirus and Epstein-barr virus infection
Time Frame
From the 1st day to 2 years after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruju Wang, MD
Phone
13912629420
Email
wrja0515@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huizhu Kang, MD
Phone
8761925608
Email
khz11826@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Han, MD/phD
Organizational Affiliation
Study Principle investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Han
Phone
+86 13901551669
Email
hanyuesz@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26899273
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.
Results Reference
result

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M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

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