Status:
COMPLETED
Safety of Expanded Haploidentical Natural Killer Cells for Leukemia
Lead Sponsor:
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Conditions:
Leukemia, Acute Myeloid
Leukemia, Acute Lymphoblastic
Eligibility:
All Genders
1-30 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to estimate the safety of ex vivo expanded haploidentical natural killer (NK) cells for patients with leukemia.
Detailed Description
Immunotherapy with natural killer (NK) cells may improve the results of treatment for patients with cancer. However, for better efficiency high doses of NK cells are required. For this purpose, NK cel...
Eligibility Criteria
Inclusion
- Patients:
- Relapsed acute myeloid or lymphoblastic leukemia
- Primary refractory myeloid or lymphoblastic leukemia
- Karnofsky or Lansky performance scale greater or equal to 70
- Written informed consent
- Donor:
- Haploidentical family donor
- \> 18 years old
- Donor suitable for cell donation and apheresis according to standard criteria
- Written informed consent
Exclusion
- Patients:
- Uncontrolled infection
- Severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age
- Positive serology for human immunodeficiency virus (HIV)
- Donors:
- Pregnancy or breast feeding
- Positive serology for HIV, hepatitis B or C.
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04327037
Start Date
January 2 2019
End Date
June 30 2021
Last Update
March 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, Belarus, 223053