RecruitingPhase 1Phase 2NCT05584761

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

A Perspective, Multicenter, Open-label and Observational Trial for Unrelated Umbilical Cord Blood Stem Cell Microtransplantation Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and Secondary AML.


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

50 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment combining donated umbilical cord blood stem cells with azacitidine-based chemotherapy for people with advanced myelodysplastic syndrome (MDS), a pre-leukemia bone marrow disease, a related condition called CMML-2, or secondary acute myeloid leukemia (AML) — in patients who cannot receive a standard bone marrow transplant. **You may be eligible if...** - You have been diagnosed with high-risk MDS, CMML-2, or AML that developed from a previous blood condition - You are not eligible for a standard allogeneic stem cell transplant (due to age, health, or other factors) - Your disease meets specific criteria based on bone marrow testing **You may NOT be eligible if...** - You are eligible for and can receive a standard stem cell transplant - You have serious organ damage or other conditions that make this treatment too risky - Other exclusion criteria as determined by your doctor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGunrelated umbilical cord blood

A single unit of unrelated umbilical cord blood was reinfused within 24-72 hours after the end of AZA or chemotherapy, and the longest delay was 96 hours after the end of chemotherapy. The umbilical cord blood was matched at 0-3/10 locus. Microtransplantation of umbilical cord blood: single unit of unrelated cord blood (HLA 0-5/10 or 0-3/6 matched, TNC 1-2×107/Kg body weight), AZA or homoharringtonine infusion 24-72 hours after the end of injection.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT05584761


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