Status:
RECRUITING
Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Higher-risk MDS
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
14-80 years
Phase:
PHASE2
Brief Summary
This study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of above-mentioned MDS patients by observing the factors related to the eff...
Eligibility Criteria
Inclusion
- 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
- Patients aged 14-80, gender and race are not limited;
- Karnofsky score ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- Expected survival time ≥ 3 months;
- 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%);
- The recipient and selected donor should be 0-3/10 HLA-matched with same blood type;
- Patients who voluntarily participate in this clinical study and have signed an informed consent.
Exclusion
- Patients who have suffered from malignant tumors;
- Patients have suffered from hematopoietic failure after chemotherapy, and have undergone ineffective blood transfusion with unknown cause;
- Patients who have undergone Class II or above surgery within 4 weeks prior to enrollment;
- Suffering from life-threatening diseases other than MDS;
- Allergic to the drugs in the research;
- 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;
- Patients with test positive for HIV, HCV or HBV;
- Stroke or intracranial hemorrhage occurred within 6 months prior to enrollment;
- Warfarin or vitamin K antagonists (such as phenprocoumarin) is necessary for anticoagulation;
- Patients with mental illnesses or cognitive impairments;
- Patients have participated within the month prior to enrollment or patients are currently participating in other clinical trials;
- There are other conditions that the investigators consider inappropriate for inclusion.
Key Trial Info
Start Date :
October 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06109064
Start Date
October 27 2023
End Date
February 1 2026
Last Update
October 31 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230001