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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time from randomization to death from any cause. | From the 1st day to 2 years after enrollment |
| incidence of GVHD | The incidence of graft-versus-host disease |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruju Wang, MD | Contact | 13912629420 | wrja0515@163.com | |
| Huizhu Kang, MD | Contact | 8761925608 | khz11826@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yue Han, MD/phD | Study Principle investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26899273 | Result | 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. |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
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| 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. |
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| From the 1st day to 2 years after enrollment |
| CMV and EBV activation | The incidencance of cytomegalovirus and Epstein-barr virus infection | From the 1st day to 2 years after enrollment |