Status:
UNKNOWN
Adoptive Immunotherapy of High Risk Acute Myeloblastic Leukemia Patients Using Haploidentical Kir Ligand-mismatched Natural Killer Cells
Lead Sponsor:
University of Bologna
Conditions:
Myeloblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00799799
Start Date
October 1 2005
End Date
December 1 2009
Last Update
September 24 2009
Active Locations (1)
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1
Institute of Hematology "L. & A. Seragnoli"
Bologna, Bo, Italy, 40138