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New treatment option for MDS/MPN
Official title Clinical Study of Azacitidine Combined With Ruxolitinib in the Treatment of Higher-risk MDS/MPN
ClinicalTrials.gov ID: NCT05817955
What this study is testing
What is Azacitidine (AZA) with Ruxolitinib?
Azacitidine (AZA) with Ruxolitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mds/mpn.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study observes the safety and efficacy of Azacitidine (AZA) combined with ruxolitinib to treat higher-risk Myelodysplastic Syndromes∕Myeloproliferative Neoplasms(MDS/MPN)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- According to WHO (2016) classification, researchers made the diagnosis of CMML based on clinical and morphological characteristics. Other criteria...
- According to the WHO (2016) classification standards (Arber 2016), researchers made the diagnosis of other types of MDS/MPN (including aCML and MDS...
- 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...
You likely can't join if
- BCR-ABL positive Chronic Myelogenous Leukemia (CML) and Ph chromosomal negative classic myeloproliferative Neoplasms, such as essential...
- 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;
- Patients who are allergic to any drug involved in the trial;
- Pregnancy, lactating Women, and patients who are unwilling to use contraceptives;
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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.
- 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;
- Patients who are allergic to any drug involved in the trial;
- Pregnancy, lactating Women, and patients who are unwilling to use contraceptives;
- Patients with abnormal Liver and kidney function which exceeded the inclusion criteria;
- Patients with organic heart disease with clinical symptoms or heart dysfunction (NYHA ≥ level 2);
- 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...
- 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...
- 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...
- Patients who can't understand or follow the research plan;
- Patients who are under 18 or over 80 years old;
- 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 with psychological disorders or cognitive disorders
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.