Acute leukemia during induction or consolidation therapy. Autologous HSCT for a hematological malignancy. Standard allogeneic HSCT with a myeloablative conditioning regimen.
Conditions
Interventions
Product Name: Cancidas
Product Code: MK-0991
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Caspofungin
CAS Number: 179463-17-3
Other descriptive name: L-000743872
Concent
Sponsors
CHU Sart-Tilman
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 3 months. · PS=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: ;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. | — |
Countries
Belgium
Outcome results
None listed