Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

NK Cell Therapy Recurrent/Refractory Elderly AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04599452
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Shandong University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
AML Recurrent Refractory Elderly Biological: Allogeneic NK cell regimen group Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Allogeneic NK Cell Therapy for Recurrent/Refractory Elderly AML
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: 1 year ]
    The proportion of patients with overall survival(OS).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  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:

  1. Malignant tumor patient.
  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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599452


Contacts
Layout table for location contacts
Contact: Chengyun Zheng, Ph.D +86-531-85875502 chengyun.zheng@ki.se

Locations
Layout table for location information
China, Shandong
The 2nd Hospital of Shandong University
Jinan, Shandong, China, 250033
Contact: Chengyun Zheng, Ph.D.    +86-531-85875502    chengyun.zheng@ki.se   
Sponsors and Collaborators
The Second Hospital of Shandong University
Investigators
Layout table for investigator information
Study Director: Chengyun Zheng, Ph.D. The Second Hospital of Shandong University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: The Second Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT04599452    
Other Study ID Numbers: 2020NKAML
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Second Hospital of Shandong University:
Recurrent/Refractory Elderly AML NK cell