E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suitable for haploidentical HCT affected by acute leukemias in 1st or subsequent complete remission and at high risk of relapse . |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060930 |
E.1.2 | Term | Acute leukaemia in remission |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the 1-year cumulative incidence of nonrelapse mortality (NRM) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT |
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E.2.2 | Secondary objectives of the trial |
To Compare overall survival in the two treatment, To Compare the time to T-cell immune reconstruction To Compare the engraftement rate To Compare the cumulative incidence of grade II -IV acute GvHD To compare the cumulative incidence of extensive chronic GvHD To compare the cumulative incidence of relapse (CIR) To compare the disease-free survival (DFS) To compare incidence and duration of infectious episodes and infectious disease mortality To evaluate the acute and long-term toxicity related to the HSV-Tk infusions To assess quality of life (QoL) and Medical Care Utilization (MCU) in both arms |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: Pharmacoeconomy Version :A Data:2009-11-04 Objective:summarize and evaluate the differences in the two treatment groups with regard to the resources used, in particular those used for diagnosis, monitoring and treatment of major events (acute and chronic GvHD, infectious episodes) Quality of life Title:Evaluation of Quality of life Versione:A Data:2009-11-04
Objective:summarize and evaluate the differences between the treatment groups in terms of benefits and patient satisfaction with therapy
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E.3 | Principal inclusion criteria |
Age ≥ 18 years • Any of the following conditions: - AML and ALL in 1st complete remission (CR) at high risk of relapse based on negative prognostic factors - AML and ALL in 2nd or subsequent CR - secondary AML in CR Absence of HLA matched family or unrelated donor • Stable clinical conditions and life expectancy >3 months • PS ECOG < 2 • Patients, or legal guardians, and donors must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects |
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E.4 | Principal exclusion criteria |
Exclusion Criteria: • Patients with life-threatening condition or complication other than their basic disease • Contraindication to haploidentical HCT as defined by the Investigator • Patients with active CNS disease • Pregnant or lactation. Patients both males and females with reproductive potential (i.e. menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration. Exclusion criteria for HSV-Tk infusion: 1. Infections requiring administration of ganciclovir, valganciclovir or acyclovir at the time of infusion: HSV-Tk cells can be administered after a 24-hour discontinuation interval of antiviral therapy 2. GvHD requiring systemic immunosuppressive therapy 3. Ongoing systemic immunosuppressive therapy after haploidentical HCT 4. Administration of G-CSF after haploidentical HCT 5. CD3+ cells ≥100 /μl at day of planned experimental infusion after haploidentical HCT. For criteria 2, 3 and 4: HSV-Tk cells can be administered after an adequate patient wash-out period |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the 1-year cumulative incidence of nonrelapse mortality (NRM) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT |
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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 | No |
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 | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Quality of life assessment |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Haploidentical haematopoietic stem cells transplantation ( without HSV-tk) |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 | Yes |
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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for Study completion date means the end of the last visit of the center because only when close out visit is performed all the data have been validated and study documentation rechecked |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
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 |