E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 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 safety and toxicity of ex vivo activated and expanded allogeneic CIK cells in patients suffering molecular, recurrence after allogeneic transplantation |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 Immunosuppressive therapy should have been withdrawn or reduced to a minimum prior to CIK cells infusion.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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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) | Yes |
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) | No |
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 | 2 |
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 |