Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK) cells after allogeneic stem cell transplantation - CIK 2

• Conditions:  Patients with haematologic malignancies (excluding CML); MedDRA version: 9.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disorders

• Registration Number: EUCTR2008-003185-26-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.