M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

Trial Title: M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

NCT ID: NCT05739630

Condition: Acute Leukemia

Conditions: Official terms:
Leukemia
Acute Disease
Cytarabine
Cyclophosphamide
Busulfan
Fludarabine
Mitoxantrone
Tacrolimus

Study type: Interventional

Study phase: Phase 2/Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: mitoxantrone liposome
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.
Arm group label: M+PTCy group

Other name: Fludarabine,Cytarabine,busulfan,Cyclophosphamide,MMF,Tacrolimus Capsules

Intervention type: Drug
Intervention name: ATG
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.
Arm group label: BuCy group

Other name: MECCNU,Hu,Cytarabine,busulfan,Cyclophosphamide,MTX,CsA

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.

Criteria for 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.

Gender: All

Minimum age: 14 Years

Maximum age: 60 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital of Soochow University

Address:
City: Suzhou
Zip: 215006
Country: China

Status: Recruiting

Contact:
Last name: Yue Han

Phone: +86 13901551669
Email: hanyuesz@163.com

Start date: January 1, 2023

Completion date: January 31, 2025

Lead sponsor:
Agency: The First Affiliated Hospital of Soochow University
Agency class: Other

Source: The First Affiliated Hospital of Soochow University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05739630