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Conditions
Interventions
Product Name: CYTOKINE INDUCED KILLER CELLS
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: 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 haematologic malignancies (excluding CML) with a molecular, cytogenetic or haematologic relapse after allogeneic transplantation (therapeutic schedule).  Patients with haematologic malignancies at high risk of relapse or progression after allogeneic BMT because being not in complete remission at time of conditioning regimen (prophylactic schedule).  Patients with an available donor willing to donate peripheral blood lymphocytes or patients transplanted with a Cord Blood Unit from which CIK cells could have been prepared at time of transplantation (immediately after thawing of the Cord Blood Unit).  Patients must give written informed consent 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:  Donors positive for HIV, HBV or HCV, or unfit to undergo leukapheresis  Patients with active acute or chronic GvHD  Positive pregnancy test of female patients and use of reliable contraceptive methods for patients of both genders.  Patients with severe psychiatric illness or any disorder that compromises ability to give truly informed consent for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The efficacy of a sequential infusion of unmanipulated DLI and CIK cells for the treatment of molecular, cytogenetic or hematologic relapse after hematopoietic stem cell transplantation or as prophylaxis of haematologic progression in patients not in remission at the time of conditioning before allogeneic transplantation.;Secondary Objective: The clinical manifestations of graft-versus-host disease induced by the sequential infusion of DLI and CIK cells. The progression- and disease-free survival and the overall survival after the sequential infusion of DLI and CIK cells.;Primary end point(s): The primary endpoint is to determine the Overall Response Rate defined as the cumulative incidence of molecular, karyotypic or haematologic responses at 1 year after the end of the cell therapy program. | — |
Countries
Italy
Outcome results
None listed