Unrelated Umbilical Cord Blood Stem Cell Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and sAML

Recruiting now · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia-2, Secondary Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT05584761

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

50

Starts

2022-03-01

Expected to finish

2026-12-31

Last updated by the study team

2022-10-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• BCR/ABL positive chronic myelogenous leukemia, primary myelofibrosis, polycythemia vera and essential thrombocythemia;
• Low risk myelodysplastic syndromes according to IPSS or revised IPSS prognostic risk categories;
• Acute promyelocytic leukemia, myeloid sarcoma, or accelerated or blastic phase of chronic myelogenous leukemia;
• Allergic to any of the mentioned agent in the study protocol;
• Pregnant or lactating women, or patients during reproductive stage but not willing to take contraception methods;
• With obvious dysfunction of liver or kidney, not fulfilling the inclusion criteria;
• With organic heart disease, which causes clinical symptoms or cardiac dysfunction ( ≥ Class 2 cardiac disease as defined by the New York Heart Association Functional Classification, NYHA );
• At the same time suffering from other malignant tumors, with the exception of the following: (1) malignancy treated with curative intent and with no evidence of active disease present for more than 5 years prior to screening; (2) adequately treated lentigo maligna melanoma without current evidence of disease or adequately-controlled non-melanomatous skin cancer (even if less than 3 years prior to screening); (3) adequately treated cervical carcinoma in situ without current evidence of disease (even if less than 3 years prior to screening);
• Known history of human immunodeficiency virus (HIV) or syphilis, or active infection with Hepatitis B (HBV-DNA positive) or Hepatitis C;
• Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or history of myocardial infarction within 6 months prior to first dose with study drug, or any Class 3 or 4 cardiac disease as defined by NYHA;
• Any concurrent medical condition or disease (eg, active systemic infection) that may interfere with the research procedure or outcome, or that the subject may have a risk to participate in the study;
• Cannot understand or follow the study protocol;
• Patients under 12 years old or over 80 years old;
• Received major surgery within 4 weeks prior to randomization;
• Participated in other clinical researches at the same time one month before enrollment;
• Cannot matching suitable cord blood stem cell;
• Addicted to illegal drugs;
• Have mental disorders or cognitive disorders.

Where it is running

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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