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Trial Title:
Adoptive Immunotherapy of High Risk Acute Myeloblastic Leukemia Patients Using Haploidentical Kir Ligand-mismatched Natural Killer Cells
NCT ID:
NCT00799799
Condition:
Myeloblastic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
Nk cells infusion
minimal residual disease in AML patients
trafficking of NK cells after infusion
cytolytic effects on leukemic cells
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
NK cells
Description:
NK cells infusion after immunosuppressive chemotherapy
Arm group label:
NK
Summary:
AML patients with de-novo or secondary disease with age greater than 18 years not
eligible for stem cell transplantation for medical contraindications, lack of donor or
lack of stem cells,are eligible. Leukemias other than AML and M3 FAB subtype will be
excluded from the study. Immunosuppressive chemotherapy prior to NK cell infusion will
include: fludarabine and cyclophosphamide 4g/m2 (Flu/Cy). The therapy will be
administered over 6 days on inpatient basis. Haploidentical NK cells will be selected
from a steady-state large volume leukapheresis product from a suitable KIR ligand
incompatible donor. Donor-recipients pairs will be selected on the basis of known KIR
ligands. In particular, haploidentical donors will be included if present at least one
allele mismatch at a class I locus among the following ones: HLA-C alleles with
Asn77-Lys80, HLA-C alleles with Ser77-Asn80, HLA-Bw4 alleles. Immunomagnetic enrichment
of NK cells will follow two subsequent steps: 1) depletion of CD3+ T cells followed by 2)
positive selection of CD56+ NK cells. Contaminating CD3+ T cells will be carefully
evaluated.
Detailed description:
When previously cryproserved NK cells are still available, further re-infusions may be
performed, according to PI's evaluation. The number of remaining NK cells must be
sufficient for the reinfusion of at least the minimum dose of cells (106/kg). At least
two months should elapse between two consecutive infusion procedures.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed informed consent.
- Performance Status ≥ 70% (Karnofsky score) or ≤ 2 (WHO).
- Age greater than 18 years.
- Availability of a KIR incompatible haploidentical donor.
- Adequate renal (serum creatinine < 2 mg/dl), pulmonary (Sat O2 ≥ 96%) and hepatic
(ALT/AST < 2.5 x N) function.
- Patients enrolled in the protocol must have an autologous graft cryopreserved to be
reinfused in case of severe myelosuppression induced by haploidentical NK cells.
Back-up cells will be reinfused in case of ANC < 0.5 x 109/L at day + 40 from the
start of immunosuppressive regimen.
Exclusion Criteria:
- Age < 18.
- People unable to give informed consent.
- HIV positivity.
- HCV positivity with high viral load.
- Intercurrent organ damage or medical problems that would interfere with therapy.
- Pregnant or nursing females.
- Current uncontrolled infection.
- No availability of a cryopreserved autologous stem cell graft to be reinfused in
case of severe myelosuppression.
- Signs or symptoms of fluid retention (e.g. pleural effusion)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology "L. & A. Seragnoli"
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Start date:
October 2005
Completion date:
December 2009
Lead sponsor:
Agency:
University of Bologna
Agency class:
Other
Source:
University of Bologna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00799799
