Safety of Expanded Haploidentical Natural Killer Cells for Leukemia

• Status: Recruiting
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to estimate the safety of ex vivo expanded haploidentical natural killer (NK) cells for patients with leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
• Treatments: Interleukin-2

Criteria

Inclusion Criteria:

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 Criteria:

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.