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Trial Title:
Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML
NCT ID:
NCT06105658
Condition:
Acute Myelocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Unrelated umbilical cord blood
Description:
The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10,
same blood type.
Arm group label:
Chemotherapy+unrelated umbilical cord blood microtransplantation
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Patients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on
days 3 to 21)
Arm group label:
Chemotherapy+unrelated umbilical cord blood microtransplantation
Intervention type:
Drug
Intervention name:
Decetabine
Description:
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)
Arm group label:
Chemotherapy+unrelated umbilical cord blood microtransplantation
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
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)
Arm group label:
Chemotherapy+unrelated umbilical cord blood microtransplantation
Summary:
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.
Criteria for 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.
Gender:
All
Minimum age:
14 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of University of Science and Technology of China
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoyu Zhu, MD
Phone:
15255456091
Email:
xiaoyuz@ustc.edu.cn
Start date:
October 2023
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06105658
