Clinical trial · Interventional
M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia
An Multicenter, Randomized, Controlled, Prospective Clinical Study of Mitoxantrone Liposome Combined With PTCy as Conditioning Regimen in Allo-HSCT in Acute Leukemia
NCT05739630CI-TRIAL-00064165unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG | Drug | — | UNRESOLVED |
| mitoxantrone liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- M+PTCy group
- 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.
- interventionNames
- Drug: mitoxantrone liposome
- type
- ACTIVE_COMPARATOR
- label
- BuCy group
- 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.
- interventionNames
- Drug: ATG
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTApperley 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