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Clinical Trial NCT06105658 for Acute Myelocytic Leukemia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML
A Clinical Study to Evaluate the Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Acute Myelocytic Leukemia
- UCB-MST&AML
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalChemotherapy+unrelated umbilical cord blood microtransplantation Intermittent infusion of HLA mismatched or incompletely matched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (G-PBSC) during routine chemotherapy without the use of immunosuppressants, abbreviated as "microtransplantation". | Unrelated Umbilical Cord Blood The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10, same blood type. Venetoclax Patients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on days 3 to 21) Decetabine Patients will be treated with Decetabine (20mg/m\^2/d on days 1 to 5) or Azacitidine (75mg/m\^2/d on days 1 to 7) Azacitidine Patients will be treated with Decetabine (20mg/m\^2/d on days 1 to 5) or Azacitidine (75mg/m\^2/d on days 1 to 7) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Complete response (CR) rate | CR rate is defined as the percentage of patients who met the following conditions:
Myelogram: naïve cells less than 5% (at least 200 nucleated cells); Hemogram: absolute neutrophil count \> 1.0×10\^9/L, platelet count \> 100×10\^9/L; Clinical diagnosis: no symptoms and signs caused by leukemia infiltration, and patients do not rely on blood transfusion. | 28±7days |
Hematopoietic recovery time | The time of absolute neutrophil count\>0.5×10\^9/L and platelet count \>30×10\^9/L for 3 consecutive days. | 28±7days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time to Progression（TTP） | Time from enrollment to objective progression of disease | 1 year |
Disease Free Survival（DFS） | From CR to recurrence or death or to the date of last follow-up | 1 year |
Overall Survival（OS） | From the beginning of treatment to death or to the date of last follow-up | 1 year |
Early mortality rate | Death within the first 3 months of induction therapy | 3 months |
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;
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.
- 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 AML;
- 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.
Anhui Provincial HospitalAnhui