bood cancer
Conditions
Interventions
In both arms (EAT and PAT), caspofungin will be given by intravenous route, at
a 70 mg loading dose on day 1 of antifungal therapy, followed by
50 mg once a day thereafter. In patients weighing more
Sponsors
European Organisation for Research in Treatment of Cancer (EORTC)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18 years or older.;- Start within 3 days before randomization, remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months OR start within 3 days before randomization, myeloablative conditioning regimen to prepare for an allogeneic HSCT. Permissible conditioning regimens are outlined in Appendix E.;- Planned hospital admission for the duration of the neutropenic phase (ANC< 0.5 x 109 /L).;- Planned oral or intravenous (I.V.) fluconazole for Candida prophylaxis at the dose of 400 mg/day; no other antifungal systemic prophylaxis is allowed.;- Patients with childbearing potential must have a negative serum pregnancy test and use effective contraceptive methods during the treatment period and for at least 3 months after the last study treatment.;- Female subjects who are lactating should discontinue nursing prior to the first dose.;- Adequate contraception in men.;- Patients of childbearing/ reproductive potential should use adequate birth control measures as defined by the investigator. By adequate birth control measures should be understood highly effective methods as defined by the Note 3 of the note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95):"A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly;such as implants, injectables, combined oral contraceptives, some IDUs, sexual abstinence or;vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on contraceptives should be addressed.";- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.;- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria
Exclusion criteria: - Previous or current history of proven or probable IFD.;- Current clinical diagnosis of pneumonia.;- Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol.;- History of allergy or any adverse reaction to echinocandin drugs (caspofungin, micafungin, or anidulafungin).;- Inadequately treated infection at study entry.;- Documented HIV infection.;- Concomitant inclusion on other clinical trial using an investigational drug.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival at 84 days after randomization. - Development of proven or probable IFD during the 42 days (6 weeks) and 84 days (12 weeks) following randomization. - Correct management, according to allocated treatment arm (i.e. appropriate administration of caspofungin in compliance to protocol, and compliance to the treatment strategy) during the 42 days (6 weeks) and 84 days after randomization. - Survival free of fungal infection during the 42 and the 84 days following randomization. - Safety as evaluated by AEs and SAEs by CTCAE criteria v4.0. - Number of days under caspofungin treatment or under another antifungal treatment administered after caspofungin (evaluation will be done at day 42 and day 84 after randomization). - Costs related to the strategy for initiating antifungal treatment and monitor antifungal treatment during the 42 days and the 84 days following randomization. For all the endpoints, the data will be collected in such a way that we will be able to assess all endpoint at 2 specific time points: 42 days after randomization and 84 days after randomization. | — |
Primary
| Measure | Time frame |
|---|---|
| Overall survival at 42 days i.e. 6 weeks after randomization. Secondary study parameters/outcome of the study (if applicable): - Overall survival at 84 days after randomization. - Development of proven or probable IFD during the 42 days (6 weeks) and 84 days (12 weeks) following randomization. - Correct management, according to allocated treatment arm (i.e. appropriate administration of caspofungin in compliance to protocol, and compliance to the treatment strategy) during the 42 days (6 weeks) and 84 days after randomization. - Survival free of fungal infection during the 42 and the 84 days following randomization. - Safety as evaluated by AEs and SAEs by CTCAE criteria v4.0. - Number of days under caspofungin treatment or under another antifungal treatment administered after caspofungin (evaluation will be done at day 42 and day 84 after randomization). - Costs related to the strategy for initiating antifungal treatment and monitor antifungal treatment during the 42 days and the 84 days following randomization. For all the endpoints, the data will be collected in such a way that we will be able to assess all endpoint at 2 specific time points: 42 days after randomization and 84 days after randomization. | — |
Countries
Netherlands
Outcome results
None listed