Patients with hematologic malignancies (excluding CML) with a hematologic or molecular relapse after allogeneic transplantation (at least 60 days should have elapsed since transplant). MedDRA version: 9.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Cytokine Induced Killer
Pharmaceutical Form: Suspension for injection
Other descriptive name: CYTOKINE INDUCED KILLER CELLS
Concentration type: equal
Sponsors
AZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with hematologic malignancies (excluding CML) with a hematologic or molecular relapse after allogeneic transplantation (at least 60 days should have elapsed since transplant). Immunosuppressive therapy should have been withdrawn or reduced to a minimum prior to CIK cells infusion. The original HLA-identical sibling or volunteer donor should be available, and willing and capable of donating lymphocytes Both patient and donor must give written informed consent according to local formats and appendix 1 Absence of serious intercurrent illness in both patient and donor Patients and donor must be negative for HBV, HCV and HIV. Negative pregnancy test of female patients and use of reliable contraceptive methods for patients of both genders. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Absence of written informed consent Patients with active CMV disease Patients with acute GvHD > grade II Donor positive for HIV, HBV or HCV, or unfit to undergo leucapheresis A positive pregnancy test or reluctance to use reliable methods of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The safety and toxicity of ex vivo activated and expanded allogeneic CIK cells in patients suffering molecular, recurrence after allogeneic transplantation;Secondary Objective: The antileukemic activity of CIK cells as assessed by their ability to restore hematologic remission or to induce reduction of tumor burden as assessed by cytogenetic or molecular evaluation of minimal residual disease 2. The survival and functional activity of in vivo expanding CIK cells as assessed by Flow cytometry of lymphocytes subpopulations in the peripheral blood. 3. The clinical manifestations of graft-versus-host disease induced by allogeneic CIK cells 4. The correlation between biological and clinical response with KIR genotyping and phenotyping of donor CIK cells 5. The correlation between biological and clinical response with expression of MICA antigens on leukemic cells.;Primary end point(s): / | — |
Countries
Italy
Outcome results
None listed