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Allogenic NK Cell Transfusion Azacitidine MDS-EB

Sponsor
The Second Hospital of Shandong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04599426
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
36.9
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for refractory MDS-EB.

Condition or Disease Intervention/Treatment Phase
  • Biological: Allogeneic NK cell regimen group
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Allogenic NK Cell Transfusion Combined With Azacitidine Therapy for the MDS-EB
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test Group

10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen.

Biological: Allogeneic NK cell regimen group
10 patients with refractory MDS-RAEB 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

Primary Outcome Measures

  1. Objective Response Rate (ORR) (PR+CR) [3 months]

    The proportion of patients with complete response(CR) or partial response(PR) as measured by International Working Group efficacy Criteria for myelodysplastic syndromes

Secondary Outcome Measures

  1. Overall survival(OS) [1 year]

    The proportion of patients with overall survival(OS).

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Patients with refractory high-risk MDS (MDS-EB1 and EB2) who had no effect of 2 courses of desitabine or CAG or desitabine + CAG.

  2. Patients with age 15 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. Women of child-bearing age have negative urine pregnancy tests before administration began, and agree to use effective contraception during the trial period up to the last follow-up.

  11. KIR mismatch between patient and umbilical cord blood.

  12. 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. Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.

  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. Lactating or pregnant women.

  10. Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).

  11. Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.

  12. Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.

  13. Patients participate in other clinical studies.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The 2nd Hospital of Shandong University Jinan Shandong China 250033

Sponsors and Collaborators

  • The Second Hospital of Shandong University

Investigators

  • Study Director: Chengyun Zheng, Ph.D., The Second Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Second Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT04599426
Other Study ID Numbers:
  • 2020.NK.MDS-EB
First Posted:
Oct 22, 2020
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
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
NK cell MDS-EB

Study Results

No Results Posted as of Oct 22, 2020