Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
According to the 2022 ELN guidelines patients with high-risk acute myeloid leukemia were randomly divided into MA-BUCY2 conditioning group and BuCy2 conditioning group,to evaluate the efficacy and safety of two conditioning regimens in haploidentical hematopoietic stem cell transplantation.
High risk acute myeloid leukemia patients were randomly divided into two groups before conditioning of haploidentical hematopoietic stem cell transplantation.The control group will use the BUCY2 conditioning,and the experimental group will use mitoxantrone liposome combined with BUCY2 for conditioning. After transplantation,we will observe the difference of one year relapse rates between two goups,also the adverse reactions of conditioning,GVHD,OS and PFS of the patients in two groups also been observed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MA-BUCY2 | Experimental | Mitoxantrone liposome 20mg/m2,ivgtt,d-11 ;Ara-C 4g/m2.d ,ivgtt,d-10- -9; BU 0.8 mg/kg q6h,ivgtt,d-8- -6; CTX 1.8 g/m2.d ,ivgtt,d-5- -4; me-CCNU 250 mg/m2,p.o,d-3; ATG 2.5 mg/Kg.d,d-5 -2; |
|
| BUCY2 | Active Comparator | Ara-C 4g/m2.d ,ivgtt,d-10- -9; BU 0.8 mg/kg q6h,ivgtt,d-8- -6; CTX 1.8 g/m2.d ,ivgtt,d-5- -4; me-CCNU 250 mg/m2,p.o,d-3; ATG 2.5 mg/Kg.d,d-5 -2; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MA-BUCY2 | Drug | Mitoxantrone liposome 20mg/m2,ivgtt,d-11 ;Ara-C 4g/m2.d ,ivgtt,d-10- -9; BU 0.8 mg/kg q6h,ivgtt,d-8- -6; CTX 1.8 g/m2.d ,ivgtt,d-5- -4; me-CCNU 250 mg/m2,p.o,d-3; ATG 2.5 mg/Kg.d,d-5 -2 |
| Measure | Description | Time Frame |
|---|---|---|
| relapse rates | blast cells in bone marrow are greater than or equal to 5%. Blast cells can be seen in peripheral blood or extramedullary relapse occurred. | one year after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | adverse reactions of conditioning regimen include nausea, vomiting, abdominal pain, diarrhea, heart, liver and kidney toxicity | from beginning of the conditioning to one month after conditioning |
| aGVHD |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Previously received doxorubicin or other anthracycline drugs, and the total cumulative dose of doxorubicin was more than 360 mg/m2;
Hypersensitivity to any study drug or its components;
Cardiac function and disease meet one of the following conditions:
Active infection of hepatitis B and hepatitis C;
Human immunodeficiency virus (HIV) infection;
Patients with other malignant tumors;
Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
Have a history of abuse of drugs;
History of mental illness or cognitive impairment; .Other researchers judged that it was not suitable for this study.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaonig wang, M.D. | Contact | 0086-18991232608 | wangxn99@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoning Wang, M.D. | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
Not provided
| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D012673 | Semustine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BUCY2 | Drug | Ara-C 4g/m2.d ,ivgtt,d-10- -9; BU 0.8 mg/kg q6h,ivgtt,d-8- -6; CTX 1.8 g/m2.d ,ivgtt,d-5- -4; me-CCNU 250 mg/m2,p.o,d-3; ATG 2.5 mg/Kg.d,d-5 -2 |
|
|
the incidence of acute graft versus host disease
| At day 100 post-transplantation |
| OS | overall survival | From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first,assessed up to 36 months. |
| PFS | progression free survival | From date of HSCT until the end of follow-up or the date of disease relapse from any cause, whichever came first,assessed up to 36 months. |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D008130 | Lomustine |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |