- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04599452
NK Cell Therapy Recurrent/Refractory Elderly AML
October 21, 2020 updated by: The Second Hospital of Shandong University
Safety and Efficacy of Allogeneic NK Cell Therapy for Recurrent/Refractory Elderly AML
The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for recurrent refractory elderly AML.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chengyun Zheng, Ph.D
- Phone Number: +86-531-85875502
- Email: chengyun.zheng@ki.se
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250033
- The 2nd Hospital of Shandong University
-
Contact:
- Chengyun Zheng, Ph.D.
- Phone Number: +86-531-85875502
- Email: chengyun.zheng@ki.se
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- Patients with age 60 years to 70 years.
- KPS greater than or equal to 60.
- ALT and AST are less than 3 times normal.
- Total bilirubin less than 1.5mg/dl(25.65umol/L).
- Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m2.
- Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.
- No pleural effusion in lungs
- Oxyhemoglobin saturation greater than or equal to 92% in normal environment.
- KIR mismatch between patient and umbilical cord blood.
- Volunteer to participate in the trial and sign the informed consent form.
Exclusion Criteria:
- Malignant tumor patient.
- 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).
- Patients with HIV, HCV positive.
- Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
- During the first 12 months of enrollment, patients with cardioangiography or stents, active angina pectoris or other clinically significant symptoms, or with cardiogenic asthma.
- Patients receiving anticoagulant therapy or with severe coagulation disorders.
- According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.
- Patients with allergies or history of allergies to biological agents used in this program.
- Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).
- Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.
- Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.
- Patients participate in other clinical studies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) (PR+CR)
Time Frame: 3 months
|
The proportion of patients with complete response(CR) or partial response(PR) as measured by response criteria definitions for acute myeloid leukemia
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival(OS)
Time Frame: 1 year
|
The proportion of patients with overall survival(OS).
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Chengyun Zheng, Ph.D., The Second Hospital of Shandong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2020
Primary Completion (Anticipated)
December 30, 2023
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
September 11, 2020
First Submitted That Met QC Criteria
October 21, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 21, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020NKAML
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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