Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2020-12-01
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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10 patients with recurrent refractory elderly AML were treated
The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for recurrent refractory elderly AML.
Allogeneic NK cell regimen group
10 patients with recurrent refractory elderly AML were treated with allogeneic NK cell regimen.
Allogeneic NK cell regimen ×3 cycle; Cyclophosphamide 300mg/m2.d d1to 3; G-CSF 150ug bid d4-11; Azacitidine 75mg/m2 d5-11; Allogeneic NK cell 10-30×10\^6/kg d13，d15.
Interventions
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Allogeneic NK cell regimen group
10 patients with recurrent refractory elderly AML were treated with allogeneic NK cell regimen.
Allogeneic NK cell regimen ×3 cycle; Cyclophosphamide 300mg/m2.d d1to 3; G-CSF 150ug bid d4-11; Azacitidine 75mg/m2 d5-11; Allogeneic NK cell 10-30×10\^6/kg d13，d15.
Eligibility Criteria
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Inclusion Criteria
2. Patients with age 60 years to 70 years.
3. KPS greater than or equal to 60.
4. ALT and AST are less than 3 times normal.
5. Total bilirubin less than 1.5mg/dl(25.65umol/L).
6. Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m2.
7. Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.
8. No pleural effusion in lungs
9. Oxyhemoglobin saturation greater than or equal to 92% in normal environment.
10. KIR mismatch between patient and umbilical cord blood.
11. Volunteer to participate in the trial and sign the informed consent form.
Exclusion Criteria
2. Patients who are accompanied by fungal, bacterial, viral, or other uncontrolled infections or require level 4 isolation( HBV-DNA quantification and normal liver function in patients with hepatitis b infection are excluded).
3. Patients with HIV, HCV positive.
4. Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
5. During the first 12 months of enrollment, patients with cardioangiography or stents, active angina pectoris or other clinically significant symptoms, or with cardiogenic asthma.
6. Patients receiving anticoagulant therapy or with severe coagulation disorders.
7. According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.
8. Patients with allergies or history of allergies to biological agents used in this program.
9. Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).
10. Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.
11. Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.
12. Patients participate in other clinical studies.
60 Years
70 Years
ALL
No
Sponsors
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The Second Hospital of Shandong University
OTHER
Responsible Party
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Principal Investigators
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Chengyun Zheng, Ph.D.
Role: STUDY_DIRECTOR
The Second Hospital of Shandong University
Locations
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The 2nd Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020NKAML
Identifier Type: -
Identifier Source: org_study_id
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