Actively Recruiting
Clinical Study of Azacitidine Combined With Ruxolitinib in the Treatment of Higher-risk MDS/MPN
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-04-18
50
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
A
Affiliated Hospital of Jiangsu University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study observes the safety and efficacy of Azacitidine (AZA) combined with ruxolitinib to treat higher-risk Myelodysplastic Syndromes∕Myeloproliferative Neoplasms(MDS/MPN)
CONDITIONS
Official Title
Clinical Study of Azacitidine Combined With Ruxolitinib in the Treatment of Higher-risk MDS/MPN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CMML or other MDS/MPN types (aCML, MDS/MPN-U) based on WHO 2016 criteria
- Neutrophil count 2x10^9/L and platelet count 25x10^9/L
- Classified as intermediate-2 or high risk by CPSS-Mol or MMM scoring systems
- Not suitable for hematopoietic stem cell transplantation per local standards
- Suitable for Azacitidine treatment per local standards
- Age between 18 and 80 years
- Liver enzymes (ALT, AST) and bilirubin no more than twice the upper normal limit
- Serum creatinine no more than 150 bcmol/L
- Serum myocardial enzyme less than twice the normal upper limit for age
- Left ventricular ejection fraction (LVEF) of at least 50%
- Estimated glomerular filtration rate (EGFR) of at least 30 ml/min/1.73m^2
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Signed informed consent form by patient or legal representative
You will not qualify if you...
- Diagnosis of BCR-ABL positive Chronic Myelogenous Leukemia or classic myeloproliferative neoplasms (ET, PV, PMF)
- Low risk or intermediate-1 risk CMML or MDS/MPN with less than 5% bone marrow blasts
- Neutrophil count below 2x10^9/L or platelet count below 25x10^9/L
- Secondary acute leukemia, myeloid sarcoma, or blast phase aCML
- Allergy to any study drug
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Liver or kidney function outside inclusion limits
- Organic heart disease with symptoms or dysfunction (NYHA level 2 or higher)
- Other active malignancies except certain treated cancers with no active disease
- AIDS, syphilis, active hepatitis B or C
- Significant cardiovascular disease including uncontrolled arrhythmia, recent myocardial infarction, or severe heart failure
- Conditions interfering with study participation or safety as judged by researchers
- Inability to understand or follow study procedures
- Age under 18 or over 80 years
- Major surgery within 4 weeks prior to randomization
- Participation in another clinical trial within 1 month prior
- Dependence on illegal drugs
- Psychological or cognitive disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
Z
Zhongxun Shi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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