NK Cell Therapy Recurrent/Refractory Elderly AML

NCT04599452 | Unknown Phase 1

• 1 other identifier: 2020NKAML
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

AML; Recurrent; Refractory; Elderly

Keywords

Recurrent/Refractory Elderly AML NK cell

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (1)

• Overall survival(OS)

  1 year

Study Arms (1)

10 patients with recurrent refractory elderly AML were treated

EXPERIMENTAL

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

Interventions

Allogeneic NK cell regimen group BIOLOGICAL

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.

10 patients with recurrent refractory elderly AML were treated

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The 2nd Hospital of Shandong University

Jinan, Shandong, 250033, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chengyun Zheng, Ph.D.

  The Second Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Chengyun Zheng, Ph.D

CONTACT

+86-531-85875502; chengyun.zheng@ki.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

CN (1)