Empirical Versus Pre-emptive (Diagnostic-driven) Antifungal Therapy of Patients Treated for Haematological Malignancies or Receiving an Allogeneic Stem Cell Transplant. A Therapeutic Open Label Phase III Strategy Study of the EORTC Infectious Diseases and Leukemia Groups

NCT01288378 Phase 3 COMPLETED

RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan. PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.

Details

Lead sponsor	European Organisation for Research and Treatment of Cancer - EORTC
Phase	Phase 3
Status	COMPLETED
Enrolment	556
Start date	2012-03
Completion	2019-04-04

Conditions

• Fungal Infection
• Leukemia
• Myelodysplastic Syndromes

Interventions

• caspofungin acetate

Primary outcomes

• Overall survival at 42 days after randomization — 6 weeks after randomization

Countries

Belgium, Czechia, France, Germany, Netherlands, Slovakia