E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
 Patients with haematologic malignancies (excluding CML) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10005329 |
E.1.2 | Term | Blood and lymphatic system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |