Tests azacitidine with ruxolitinib for higher-risk MDS/MPN blood disease

Trial details

Who runs it

The First Affiliated Hospital with Nanjing Medical University

Trial code

NCT05817955

Record updated

18 April 2023

Original description

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

Clinical Study of Azacitidine Combined With Ruxolitinib in the Treatment of Higher-risk Myelodysplastic Syndromes∕Myeloproliferative Neoplasms

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

Inclusion: According to WHO (2016) classification, researchers made the diagnosis of CMML based on clinical and morphological characteristics. Other criteria should be met: 1) Neut ≥2x109/L, PLT ≥25x109/L, 2) belongs to the following prognostic risk group according to CPSS-MOL or MMM : CPSS-MOL: inter-2 risk (2 to 3 points); high risk (≥4 points); MMM: inter-2 risk (2.5 to 4.5 points); high risk (≥5 points), or:; 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; Age is between 18 to 80 years old; ALT, AST and serum bilirubin is no more than 2 times of the upper limit of normal values (ULN), serum creatinine is no more than 150 μmol/L, and serum myocardial enzyme is less than (the same age) 2 times of normal value upper limit; The LVEF determined by the echocardiography is no less than 50%; Estimated glomerular filtration rate (EGFR) is no less than 30ml · min · 1.73m2; Eastern Tumor Collaboration Group (ECOG) physical states score is 0 to 2; Informed Consent Form is signed by patients or legal agents.

Exclusion: Patients with other malignancies at the same time except the following situations:; Patients had received treatment for the purpose of cure and had no active malignancies for at least 5 years prior to enrollment; 2)Patients had received sufficient treatment, non-melanoma skin cancer or malignant freckles -like moles with no signs of illness (even if random grouping is less than 3 years); 3)Received sufficient treatment, in situ cancer without signs of illness (even if the random group is less than 3 years); Patients who underwent a major surgery within 4 weeks before the random grouping; Patients who are participating in other clinical trials one month before joining the group; Patients who rely on illegal drugs; Patients who are allergic to any drug involved in the trial; Patients with organic heart disease with clinical symptoms or heart dysfunction (NYHA ≥ level 2); Patients with AIDS, syphilis, active hepatitis B (HBV-DNA can be measured) and hepatitis C; Patients with cardiovascular diseases with clinical significance, such as arrhythmia that have not been controlled or have symptoms, congestive heart failure or myocardial infarction within 6 months, or level 3 (moderate) or level 4 (Severe) heart disease (NYHA according to the New York Heart Society's functional grading method); Patients with any situations that might interfere with research procedures or results, or have the medical status or disease that will bring a certain risk to participating in this study judged by researchers (such as activity systemic infection); Patients with psychological disorders or cognitive disorders; Patients with Neut<2x109/L, PLT<25x109/L; Patients who are under 18 or over 80 years old; 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; Secondary acute leukemia, myeloid sarcoma, and blast phase of aCML; Pregnancy, lactating Women, and patients who are unwilling to use contraceptives; Patients with abnormal Liver and kidney function which exceeded the inclusion criteria; Patients who can't understand or follow the research plan.

ClinicalTrials.gov NCT05817955