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This study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of AML patients by observing the factors related to the efficacy and adverse reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy+unrelated umbilical cord blood microtransplantation | Experimental | 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". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unrelated umbilical cord blood | Biological | The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10, same blood type. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lymphocyte subsets (NK cells, T cells) before and after treatment | The concentration of lymphocyte subsets in peripheral blood can be detected by flow cytometry | At the time of enrollment and at 1 month |
| Correlation between human leukocyte antigen (HLA) matching and the concentration of lymphocyte subsets |
Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyu Zhu, MD | Contact | 15255456091 | xiaoyuz@ustc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyu Zhu, MD | The First Affiliated Hospital of University of Science and Technology of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Recruiting | Hefei | Anhui | 230001 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Venetoclax | Drug | 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 | Drug | 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 | Drug | 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) |
|
| 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 |
HLA typing and matching can be assessed by sequence based genotyping (PCR-SBT), and the concentration of lymphocyte subsets in peripheral blood can be detected by flow cytometry |
| HLA typing and matching will be assessed at the time of enrollment, and the concentration of lymphocyte subsets in peripheral blood will be detected at the time of enrollment and at 1 month |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |