Using umbilical cord blood microtransplantation for treating higher-risk MDS

A Clinical Study to Evaluate the Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Higher-risk Myelodysplastic Syndromes

This study is testing if using umbilical cord blood along with certain medications can safely help people aged 14-80 with higher-risk myelodysplastic syndromes feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 14 Years to 80 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06109064 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of unrelated umbilical cord blood microtransplantation in patients diagnosed with higher-risk myelodysplastic syndromes (MDS). It involves administering umbilical cord blood along with medications such as Venetoclax, Decitabine, and Azacitidine to assess treatment outcomes and monitor for adverse reactions. The study aims to include patients aged 14-80 with specific health criteria and HLA-matching requirements. By observing the effects of this innovative approach, the study seeks to provide insights into potential new treatment options for MDS.

Who should consider this trial

Good fit: Ideal candidates are patients aged 14-80 diagnosed with higher-risk MDS and meeting specific health criteria.

Not a fit: Patients with lower-risk MDS or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a new treatment option for patients with higher-risk MDS, potentially improving their outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using umbilical cord blood for transplantation, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients diagnosed with MDS with WHO criteria through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. Patients can be newly diagnosed, recurrent or unresponsive, with International prognostic scoring system (IPSS-R) score\> 3.5
2. Patients aged 14-80, gender and race are not limited;
3. Karnofsky score ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
4. Expected survival time ≥ 3 months;
5. The examination results meet the following requirements:

   ALT and AST ≤ 3 × Upper limit of normal value (ULN); Total bilirubin ≤ 3 × ULN; Creatinine ≤ 2 × ULN or creatinine clearance rate ≥ 40mL/min; The left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scanning is within the normal range (\>50%);
6. The recipient and selected donor should be 0-3/10 HLA-matched with same blood type;
7. Patients who voluntarily participate in this clinical study and have signed an informed consent.

Exclusion Criteria:

1. Patients who have suffered from malignant tumors;
2. Patients have suffered from hematopoietic failure after chemotherapy, and have undergone ineffective blood transfusion with unknown cause;
3. Patients who have undergone Class II or above surgery within 4 weeks prior to enrollment;
4. Suffering from life-threatening diseases other than MDS;
5. Allergic to the drugs in the research;
6. Patient with severe cardiac insufficiency, including uncontrolled or symptomatic arrhythmia, congestive heart failure, myocardial infarction within 6 months, or any grade 3 (moderate) or grade 4 (severe) heart disease;
7. Patients with test positive for HIV, HCV or HBV;
8. Stroke or intracranial hemorrhage occurred within 6 months prior to enrollment;
9. Warfarin or vitamin K antagonists (such as phenprocoumarin) is necessary for anticoagulation;
10. Patients with mental illnesses or cognitive impairments;
11. Patients have participated within the month prior to enrollment or patients are currently participating in other clinical trials;
12. There are other conditions that the investigators consider inappropriate for inclusion.

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (Recruiting)

Study contacts

• Principal investigator: Xiaoyu Zhu, MD — The First Affiliated Hospital of University of Science and Technology of China
• Study coordinator: Xiaoyu Zhu, MD

Conditions Myelodysplastic Syndromes