Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML

Launched by ANHUI PROVINCIAL HOSPITAL · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with Acute Myelocytic Leukemia (AML) using umbilical cord blood microtransplantation. The goal is to see if this method is safe and effective for patients who have recently been diagnosed and have not yet received treatment. The researchers are looking for participants aged 14 to 80 who meet specific health criteria, such as having a certain level of overall health and expected survival time of at least three months. Importantly, candidates must also be willing to join the study and provide informed consent.

If you or a loved one participates in this trial, you can expect to undergo monitoring for any side effects and to see how well the treatment works. The study is currently recruiting participants, and it is essential that individuals do not have other serious health conditions or have recently undergone major surgeries. This trial aims to offer hope to those battling AML by exploring a potentially new treatment option that uses stem cells from umbilical cord blood.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Patients diagnosed with AML through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. Besides, patients should meet the following conditions:
• • Patients aged 60-80 who newly diagnosed AML with WHO criteria and have not received prior treatment for acute leukemia (hydroxyurea or pre-chemotherapy is allowed for patients with high leukocyte).
• • Patients aged 14-60 who do not meet the indications for hematopoietic stem cell transplantation;
• • 2. 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 AML;
• • 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.