Clinical Study of Azacitidine Combined With Ruxolitinib in the Treatment of Higher-risk MDS/MPN

ConditionMDS/MPN
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

This study observes the safety and efficacy of Azacitidine (AZA) combined with ruxolitinib to treat higher-risk Myelodysplastic Syndromes∕Myeloproliferative Neoplasms(MDS/MPN)

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Azacitidine (AZA) with Ruxolitinib

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

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