Invasive aspergillosis in patients with haematological malignancies (HM)/autologous Hematopoietic Stem Cell Transplantation (HSCT) – group A- and patients with allogeneic HSCT transplantation – group B MedDRA version: 7.1 Level: LLT Classification code 10003488
Conditions
Interventions
Product Name: Coaspofungin Acetate
Product Code: MK-0991
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Caspofungin
CAS Number: 179463-17-3
Current Sponsor code: MK-0991
Ot
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients eligible for this study will be patients 18 years of age or older with HM/auto-HSCT or allo-HSCT and with a diagnosis of proven or probable IA, according to EORTC-MSG criteria. All patients must be followed in centers belonging to the EORTC network. - The inclusion of patients with possible IA will be allowed. However, study drug treatment should be stopped if the case cannot be upgraded to probable or proven IA within 7 days after enrolment, based on tests already performed prior to or within 48 hrs after registration into the study, but with pending results. These include culture and/or histology results and Aspergillus galactomannan evaluations. - A course of no more than 72 hours of empirical antifungal therapy, not including an echinocandin, prior to enter into the study will be allowed. - Oral antifungal prophylaxis is allowed, but prophylaxis must be discontinued at study entry. - Intravenous fluconazole for prophylaxis is allowed, but prophylaxis must be discontinued at study entry. - Absence of a history of allergy or any adverse reaction to echinocandin drugs - Absence of severe renal failure requiring hemodialysis or peritoneal dialysis and a serum creatinine level lower than 300 µmol/L or 3.4 mg/dL - Absence of significant liver function test abnormalities, defined as an increase in ASAT/ALAT higher than 5x upper normal limits (UNL) or total serum bilirubin/ALP 5xUNL. - Patients with severe hepatic insufficiency are excluded - Karnofski performance status score = 20. Comatose and moribund patients or those who have little hope of recovery are excluded - Absence of known bacterial infection not adequately treated at time of enrolment - Pregnant and lactating women are excluded. Women of child bearing potential should have a negative pregnancy test within 7 days from registration. - Patients receiving an investigational agent within 14 days prior to study entry or during the study course will be excluded. - Absence of documented HIV infection - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to estimate the activity of caspofungin as first line therapy in the treatment of Invasive aspergillosis in patients with haematological malignancies (HM)/autologous Hematopoietic Stem Cell Transplantation (HSCT) – group A- and patients with allogeneic HSCT transplantation – group B. The activity of caspofungin will be assessed separately in these two groups of patients since response rates and survival differ substantially in these 2 patient populations. ;Secondary Objective: ;Primary end point(s): The primary endpoint of the study will be the response rate at the end of caspofungin therapy using the standard response assessment criteria as defined in the protocol. | — |
Countries
Belgium, Germany, Italy, Spain, United Kingdom
Outcome results
None listed