Using unrelated umbilical cord blood for treating acute myelocytic leukemia

A Clinical Study to Evaluate the Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Acute Myelocytic Leukemia

This study is testing whether using umbilical cord blood as a treatment can help people aged 14-80 with acute myelocytic leukemia who haven't had treatment before.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 14 Years to 80 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (other gov)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06105658 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of unrelated umbilical cord blood microtransplantation in patients diagnosed with acute myelocytic leukemia (AML). It focuses on patients aged 14-80 who have not received prior treatment for AML and assesses both the effectiveness of the treatment and any adverse reactions. The intervention includes the use of umbilical cord blood along with medications such as Venetoclax, Decitabine, and Azacitidine. The study aims to gather data on patient outcomes and safety profiles associated with this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates are patients aged 14-80 with newly diagnosed AML who have not undergone prior treatment for acute leukemia.

Not a fit: Patients with advanced stages of AML or those who have already received treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with AML, potentially improving survival rates and quality of life.

How similar studies have performed: While the use of umbilical cord blood in transplantation has been explored, this specific approach in AML is relatively novel and has not been extensively tested in prior studies.

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.

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: Acute Myelocytic Leukemia