- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04327037
Safety of Expanded Haploidentical Natural Killer Cells for Leukemia
Pilot Study of Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Leukemia
Study Overview
Status
Intervention / Treatment
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 cells were expanded in the presence of feeder K562 cells gene-modified for expression 4-1BBL and membrane bound IL-21. In the result of expansion, large number of activated NK cells are obtained.
Protocol of immunotherapy includes conditioning (fludarabine + cyclophosphamide or any other protocol of chemotherapy) followed by expanded NK cells intravenous infusion. To sustain proliferation of donor NK cells in vivo patients receive 6 doses of Il-2 every second day. 10 patients will be enrolled in phase I to test different doses of NK cells: 20, 50, 70, 100 and >100 x 10^6/kg.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Minsk Region
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Minsk, Minsk Region, Belarus, 223053
- Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NK cells + IL-2
After cycle of chemotherapy patient receive one intravenous infusion of expanded haploidentical NK cells on day 0. On alternate days, 6 doses of subcutaneous IL-2 is administered with start on day -1.
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One dose (from 20x to >100x 10^6 /kg) of expanded haploidentical NK cells
6 doses of IL-2 (1 × 10^6 units/m2) from -1 day every other day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
Time Frame: 1 months
|
Adverse events will be graded according to the CTCAE v4.0
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1 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days of persistence of adoptively-transferred haploidentical NK cells
Time Frame: 1 months
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Analysis of donor chimerism at +2, 6, 10, 14, 21, 28 days after NK infusion.
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1 months
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Occurrence of disease response
Time Frame: 1 months post infusion
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Analysis of blast cells content in bone marrow by cytomorphology or detection of MRD level by flow/PCR before and after immunotherapy.
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1 months post infusion
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Median time to leukocytes and platelets recovery
Time Frame: 2 months post infusion
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Days of platelets (>50x10^9/L) and leukocytes (>1x10^9/L) recovery.
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2 months post infusion
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Number of T, B, NK, activated T and NK cells after immunotherapy
Time Frame: 1 months post infusion
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Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) at +2, 6, 10, 14, 21, 28 days after NK infusion.
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1 months post infusion
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Collaborators and Investigators
Investigators
- Principal Investigator: Olga Aleinikova, Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Leukemia, Lymphoid
- Leukemia, Myeloid
- Leukemia
- Leukemia, Myeloid, Acute
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Acute Disease
Other Study ID Numbers
- BelarusianPediatric_NK_Pilot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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