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Adoptive Immunotherapy of High Risk Acute Myeloblastic Leukemia Patients Using Haploidentical Kir Ligand-mismatched Natural Killer Cells


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Myeloblastic Leukemia

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Trial Information

Adoptive Immunotherapy of High Risk Acute Myeloblastic Leukemia Patients Using Haploidentical Kir Ligand-mismatched Natural Killer Cells


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the feasibility of the selection and reinfusion of 5x10E6 haploidentical natural killer (NK) cells /Kg of body weight (target cell dose) in at least 40% of adult patients with active acute myeloblastic leukemia (AML) entering the study

Outcome Time Frame:

every 6 months

Safety Issue:

Yes

Authority:

Italy: Ethics Committee

Study ID:

NK TRIAL

NCT ID:

NCT00799799

Start Date:

October 2005

Completion Date:

December 2009

Related Keywords:

  • Myeloblastic Leukemia
  • Nk cells infusion
  • minimal residual disease in AML patients
  • trafficking of NK cells after infusion
  • cytolytic effects on leukemic cells
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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