E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute leukemia during induction or consolidation therapy. Autologous HSCT for a hematological malignancy. Standard allogeneic HSCT with a myeloablative conditioning regimen.
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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 |
To assess the safety, tolerance and efficacy of caspofungin use as secondary prophylaxis for invasive fungal infections in patients with high-risk hematological malignancies undergoing intensive chemotherapy or hematopoietic stem cell transplantation. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Previous probable or proven fungal infection according to the EORTC criteria in patients with further treatment planned. · Patient categories : - Acute leukemia during induction or consolidation therapy. - Autologous HSCT for a hematological malignancy. - Standard allogeneic HSCT with a myeloablative conditioning regimen. · Male or female; female patients must use a reliable contraception method. · Age >= 18 yrs and <= 70 yrs · Life expectancy >= 3 months. · PS<= 2 · Written informed consent given by patient.
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E.4 | Principal exclusion criteria |
· HIV positive patients · Known allergy to ecchinocandins. · Alteration of liver enzymes : ASLT > 5 x Normal, bilirubin > 3 x Normal · Previous proven or probable invasive fungal infection shown to be resistant to caspofungin.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the incidence of probable or proven invasive fungal infection requiring further anti-fungal therapy including amphotericin B, voriconazole or equivalent agents during and up to one month after caspofungin prophylaxis. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | No |
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
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a) Individual patient : Caspofungin will be stopped in case of severe adverse event, suspected to be related to the drug, intolerance or development of a probable or proven fungal infection requiring further treatment. In the latter case, antifungal therapy with a standard amphotericin B, a lipid formulation of amphotericin B or voriconazole or equivalent agent will be initiated. b) Overall trial : one month after Caspofungin stopped in last of 20 patients. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |