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NK Cell Therapy Recurrent/Refractory Elderly AML

Primary Purpose

AML, Recurrent, Refractory

Status

Not yet recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Allogeneic NK cell regimen group

About this trial

This is an interventional treatment trial for AML focused on measuring Recurrent/Refractory Elderly AML NK cell

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The 2nd Hospital of Shandong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

10 patients with recurrent refractory elderly AML were treated

Arm Description

The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for recurrent refractory elderly AML.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) (PR+CR)

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)

The proportion of patients with overall survival(OS).

Full Information

NCT ID

NCT04599452

First Posted

September 11, 2020

Last Updated

October 21, 2020

Sponsor

The Second Hospital of Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT04599452

Brief Title

NK Cell Therapy Recurrent/Refractory Elderly AML

Official Title

Safety and Efficacy of Allogeneic NK Cell Therapy for Recurrent/Refractory Elderly AML

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2020 (Anticipated)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Second Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

AML, Recurrent, Refractory, Elderly

Keywords

Recurrent/Refractory Elderly AML NK cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

10 patients with recurrent refractory elderly AML were treated

Arm Type

Experimental

Arm Description

The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for recurrent refractory elderly AML.

Intervention Type

Biological

Intervention Name(s)

Allogeneic NK cell regimen group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR) (PR+CR)

Description

The proportion of patients with complete response(CR) or partial response(PR) as measured by response criteria definitions for acute myeloid leukemia

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Overall survival(OS)

Description

The proportion of patients with overall survival(OS).

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chengyun Zheng, Ph.D

Phone

+86-531-85875502

chengyun.zheng@ki.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chengyun Zheng, Ph.D.

Organizational Affiliation

The Second Hospital of Shandong University

Official's Role

Study Director

Facility Information:

Facility Name

The 2nd Hospital of Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250033

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chengyun Zheng, Ph.D.

Phone

+86-531-85875502

chengyun.zheng@ki.se

12. IPD Sharing Statement

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NK Cell Therapy Recurrent/Refractory Elderly AML

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