NK Cell Therapy Recurrent/Refractory Elderly AML
Study Details
Study Description
Brief Summary
The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for recurrent refractory elderly AML.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Biological: 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.
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) (PR+CR) [3 months]
The proportion of patients with complete response(CR) or partial response(PR) as measured by response criteria definitions for acute myeloid leukemia
Secondary Outcome Measures
- Overall survival(OS) [1 year]
The proportion of patients with overall survival(OS).
Eligibility Criteria
Criteria
Inclusion Criteria:
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The 2 or more than 2-cycles of standard regimen was used to treat elderly AML patients who did not achieve complete remission or relapse.
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Patients with age 60 years to 70 years.
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KPS greater than or equal to 60.
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ALT and AST are less than 3 times normal.
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Total bilirubin less than 1.5mg/dl(25.65umol/L).
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Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m2.
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Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.
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No pleural effusion in lungs
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Oxyhemoglobin saturation greater than or equal to 92% in normal environment.
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KIR mismatch between patient and umbilical cord blood.
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Volunteer to participate in the trial and sign the informed consent form.
Exclusion Criteria:
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Malignant tumor patient.
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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).
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Patients with HIV, HCV positive.
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Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
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During the first 12 months of enrollment, patients with cardioangiography or stents, active angina pectoris or other clinically significant symptoms, or with cardiogenic asthma.
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Patients receiving anticoagulant therapy or with severe coagulation disorders.
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According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.
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Patients with allergies or history of allergies to biological agents used in this program.
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Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).
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Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.
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Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.
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Patients participate in other clinical studies.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The 2nd Hospital of Shandong University | Jinan | Shandong | China | 250033 |
Sponsors and Collaborators
- The Second Hospital of Shandong University
Investigators
- Study Director: Chengyun Zheng, Ph.D., The Second Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020NKAML