M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

NCT05739630 | Unknown Phase 2

• 1 other identifier: 2023003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival (OS)

  From the 1st day to 2 years after enrollment

• incidence of GVHD

  From the 1st day to 2 years after enrollment

• CMV and EBV activation

  From the 1st day to 2 years after enrollment

Study Arms (2)

M+PTCy group

EXPERIMENTAL

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.

Drug: mitoxantrone liposome

BuCy group

ACTIVE COMPARATOR

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.

Drug: ATG

Interventions

mitoxantrone liposome 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.

Also known as: Fludarabine,Cytarabine,busulfan,Cyclophosphamide,MMF,Tacrolimus Capsules

M+PTCy group

ATG 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.

Also known as: MECCNU,Hu,Cytarabine,busulfan,Cyclophosphamide,MTX,CsA

BuCy group

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Related 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 Mar;22(3 Suppl):S15-8. doi: 10.1016/j.bbmt.2016.01.006.

  PMID: 26899273 RESULT

MeSH Terms

Interventions

fludarabine

Study Officials

• Yue Han, MD/phD

  Study Principle investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruju Wang, MD

CONTACT

13912629420; wrja0515@163.com

Huizhu Kang, MD

CONTACT

8761925608; khz11826@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: January 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2025
• Last Updated: February 22, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)