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Status unknownNCT04599452Updated Oct 22, 2020

NK Cell Therapy Recurrent/Refractory Elderly AML

A Phase 1/2 interventional study of Allogeneic NK cell regimen group in AML, Recurrent and Refractory, sponsored by The Second Hospital of Shandong University. Status unknown at 1 site in China. Open to participants aged 60 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by The Second Hospital of Shandong University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
60 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • AML
  • Recurrent
  • Refractory
  • Elderly

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Keywords

  • Recurrent/Refractory Elderly AML NK cell
03

In context

Recurrence

4,278 studies on the registry are indexed under Recurrence; 987 are open to participants now.

This study's planned enrollment of 10 is below the median of 50 across 3,373 interventional studies indexed under Recurrence.

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Lead sponsor

The Second Hospital of Shandong University is the lead sponsor of 33 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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

Interventions

  • BiologicalAllogeneic 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.

06

What researchers measure

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

    Time frame: 3 months

Secondary outcomes

  1. Overall survival(OS)

    The proportion of patients with overall survival(OS).

    Time frame: 1 year

07

Study locations

1 site
  • The 2nd Hospital of Shandong University
    Jinan, Shandong 250033, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04599452
Lead sponsor
The Second Hospital of Shandong University
Responsible party
Sponsor
First posted
Oct 22, 2020
Start date
Dec 1, 2020 (estimated)
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Oct 22, 2020

Study contacts

Chengyun Zheng, Ph.D
Contact
chengyun.zheng@ki.se
+86-531-85875502
Chengyun Zheng, Ph.D.
study director · The Second Hospital of Shandong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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