This study observes the safety and efficacy of Azacitidine (AZA) combined with ruxolitinib to treat higher-risk Myelodysplastic Syndromes∕Myeloproliferative Neoplasms(MDS/MPN)
According to the WHO (2016) classification standards (Arber 2016), researchers made the diagnosis of other types of MDS/MPN (including aCML and MDS /MPN-U) based on clinical and morphological characteristics. Other criteria should be met: 1) Neut ≥2x109/L, PLT ≥25x109/L, 2) Bone marrow blasts ≥5%;
Patients who are not suitable for hematopoietic stem cell transplantation (HSCT) according to the local medical standards and treatment guidelines;
Patients who are suitable for Azacitidine(AZA) treatment according to the local medical standards and treatment guidelines;
BCR-ABL positive Chronic Myelogenous Leukemia (CML) and Ph chromosomal negative classic myeloproliferative Neoplasms, such as essential thrombocytosis (ET), polycythemia vera (PV) and primary myelofibrosis (PMF) are excluded;
BCR-ABL positive Chronic Myelogenous Leukemia (CML) and Ph chromosomal negative classic myeloproliferative Neoplasms, such as essential thrombocytosis (ET), polycythemia vera (PV) and primary myelofibrosis (PMF) ;
Low risk or inter-1 risk CMML patients according to CPSS-MOL or MMM scores; other types of MDS/MPN with less than 5% bone marrow blasts;
Patients with Neut<2x109/L, PLT<25x109/L;
Secondary acute leukemia, myeloid sarcoma, and blast phase of aCML;
Single group
Azacitidine (AZA) with Ruxolitinib
Drug1. Antibiotics: Antibiotic treatment is positively given when symptoms related to infection, and other support treatment is strengthened. 2. Blood products: Infuse the blood products according to the patient's blood routine test. Drugs that need to be used by other diseases must be recorded in detail in the case report form, including the general name of the drug, the dosage of the medication, and the frequency of administration. Drugs are not allowed to be combined: Avoiding the use of granulocyte colony-stimulating factor (G-CSF), there may be risk of spleen rupture.
complete response rate
Complete remission was achieved according to the remission criteria of MDS/MPN
overall survival
It is measured from the date of randomization to the date of death from any cause; patients not known to have died at least follow-up are censored on the date they were last known to be alive.
overall response rate
overall response includes all the response according to the remission criteria of MDS/MPN
progression-free survival
The progression-free survival was calculated as the time from randomization to disease recurrence or death due to disease progression
Early mortality
Early mortality was defined as death within the first 3 months after initiation of induction therapy
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Affiliated Hospital of Jiangsu University
Collaborator
The Second Hospital of Nanjing Medical University
Collaborator
Jiangning Hospital Affiliated to Nanjing Medical University
Collaborator
