M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

NCT ID: NCT05739630

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-01-31

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.

Conditions

Acute Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

M+PTCy group

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.

Group Type: EXPERIMENTAL

mitoxantrone liposome

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

ATG

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Fludarabine,Cytarabine,busulfan,Cyclophosphamide,MMF,Tacrolimus Capsules; MECCNU,Hu,Cytarabine,busulfan,Cyclophosphamide,MTX,CsA

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yue Han, MD/phD

Role: PRINCIPAL_INVESTIGATOR

Study Principle investigator

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruju Wang, MD

Role: CONTACT

wrja0515@163.com

13912629420

Huizhu Kang, MD

Role: CONTACT

khz11826@sina.com

8761925608

Facility Contacts

Yue Han

Role: primary

hanyuesz@163.com

+86 13901551669

References

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.

Reference Type: RESULT

PMID: 26899273 (View on PubMed)

Other Identifiers

2023003

Identifier Type: -

Identifier Source: org_study_id