E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hematological malignancies at high risk of relapse based on disease progression or presence of negative prognostic factor, who have received a HCTfrom donor HLA mismatched (haploidentical) for 2 or 3 loci. |
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MedDRA Classification |
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 |
Evaluation of clinical activity in terms of immune reconstitution after SCT Evaluation of the in vivo control of GvHD after administration of ganciclovir in patients treated with HSV-tk transduced cells Evaluation of GvL effect |
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E.2.2 | Secondary objectives of the trial |
Disease free survival and overall survival Incidence of infectious events Acute and long-term toxicity related to the infusions
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients > 18 years old affected by hematological malignancies at high risk of relapse based on disease progression or presence of negative prognostic factors, who have received a SCT from a HLA mismatched (haploidentical) donor for 2 or 3 loci - Engraftment verified by >500 neutrophils/µl for three consecutive days in the absence of growth factors - Mixed chimerism or full donor chimerism confirmed - AML in 1st or 2nd relapse or primary refractory - High-risk AML in 1st or subsequent remission - RAEB and RAEB-T - CML in 2nd chronic phase, blast crisis or accelerated phase - Poor prognosis ALL in 1st or subsequent remission - High grade lymphomas in 3rd or subsequent remission - Multiple myeloma in advanced stage relapsing or progressing after high dose chemotherapy - Absence of fully HLA matched or one HLA locus mismatched family donor - Stable clinical conditions and life expectancy > 3 months - PS Karnofsky >=70 - Written donor/patient informed consent |
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E.4 | Principal exclusion criteria |
- Infection with Cytomegalovirus being treated with ganciclovir - Presence of GvHD grade > I that requires systemic immunosuppressive therapy - Ongoing systemic immunosuppressive therapy - Ongoing acyclovir administration - Administration after SCT of G-CSF and cyclosporine A - CD3+ lymphocytes >=100/μl before day +42 after SCT - Patients with life-threatening condition or complication other than their basic disease. - Patients with CNS disease - Pregnant or lactating women |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints of the trial is to evaluate the clinical activity in terms of immune reconstitution after SCT, to evaluate the in vivo control of GvHD after administration of ganciclovir and to evaluate the GvL effect. |
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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 | Yes |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |