Actively Recruiting
Unrelated Umbilical Cord Blood Stem Cell Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and sAML
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2022-10-18
50
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research is being done to study the efficacy and safety of unrelated umbilical cord blood stem cell microtransplantation combined with azacitidine(AZA) based treatment for advanced myelodysplastic syndromes(MDS), Chronic myelomonocytic leukemia-2(CMML-2) and secondary acute myeloid leukemia(sAML). The study protocol involved unrelated umbilical cord blood stem cell combined with azacitidine based treatment, which including azacitidine alone and azacitidine plus a targeted agent or chemotherapy agent.
CONDITIONS
Official Title
Unrelated Umbilical Cord Blood Stem Cell Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and sAML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with MDS using WHO 2016 criteria and classified as intermediate, high, or very high risk by IPSS
- Diagnosed with CMML-2 using WHO 2016 criteria with WBC less than 13x10^9/L
- Diagnosed with AML with prior myeloid neoplasm history using WHO 2016 criteria
- Ineligible for allogeneic hematopoietic stem cell transplantation by local medical standards
- Indicated for azacitidine treatment per local medical guidelines
- Excluded BCR/ABL positive chronic myelogenous leukemia and other specified myeloid neoplasms
- Aged 18 to 80 years
- Liver enzymes (ALT, AST) and bilirubin at or below twice the upper normal limit
- Serum creatinine at or below 150 umol/L
- Myocardial enzymes below twice the upper normal limit for age
- Left ventricular ejection fraction 50% or higher
- Estimated glomerular filtration rate 30 mL/min/1.73m2 or higher
- ECOG performance status of 0 to 2
- Signed informed consent form
You will not qualify if you...
- Diagnosed with BCR/ABL positive chronic myelogenous leukemia, primary myelofibrosis, polycythemia vera, or essential thrombocythemia
- Classified as low risk myelodysplastic syndromes by IPSS
- Diagnosed with acute promyelocytic leukemia, myeloid sarcoma, or accelerated/blastic phase chronic myelogenous leukemia
- Allergic to any study medication
- Pregnant, lactating, or unwilling to use contraception during reproductive stage
- Severe liver or kidney dysfunction not meeting inclusion criteria
- Organic heart disease causing symptoms or dysfunction (NYHA class 2 or higher)
- Having other active malignant tumors except certain treated cancers without active disease
- Known HIV or syphilis infection, or active Hepatitis B or C infection
- Active serious cardiovascular disease or recent myocardial infarction
- Any medical condition that increases study risk or interferes with procedures
- Unable to understand or follow study protocol
- Under 12 or over 80 years old
- Major surgery within 4 weeks before randomization
- Participated in other clinical trials within 1 month before enrollment
- Unable to find suitable cord blood stem cell match
- Addiction to illegal drugs
- Mental or cognitive disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
F
Fei Huang, 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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