Leukemia, Acute Lymphoblastic Clinical Trial
Official title:
Pilot Study of Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Leukemia
The purpose of this study is to estimate the safety of ex vivo expanded haploidentical natural killer (NK) cells for patients with leukemia.
Status | Completed |
Enrollment | 10 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 30 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belarus | Belarussian Research Center for Pediatric Oncology, Hematology and Immunology | Minsk | Minsk Region |
Lead Sponsor | Collaborator |
---|---|
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology |
Belarus,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events | Adverse events will be graded according to the CTCAE v4.0 | 1 months | |
Secondary | Days of persistence of adoptively-transferred haploidentical NK cells | Analysis of donor chimerism at +2, 6, 10, 14, 21, 28 days after NK infusion. | 1 months | |
Secondary | Occurrence of disease response | Analysis of blast cells content in bone marrow by cytomorphology or detection of MRD level by flow/PCR before and after immunotherapy. | 1 months post infusion | |
Secondary | Median time to leukocytes and platelets recovery | Days of platelets (>50x10^9/L) and leukocytes (>1x10^9/L) recovery. | 2 months post infusion | |
Secondary | Number of T, B, NK, activated T and NK cells after immunotherapy | Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) at +2, 6, 10, 14, 21, 28 days after NK infusion. | 1 months post infusion |
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