NCT03019939

Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia

A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well isavuconazole works in preventing invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia. Isavuconazole may help to prevent invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia.

Detailed description

PRIMARY OBJECTIVES: I. To assess whether prophylaxis with isavuconazole effectively prevents the occurrence of proven or probable invasive fungal infections (IFIs) in patients with newly diagnosed acute myeloid leukemia/myelodysplastic syndrome (AML/MDS) receiving successive cycles of intensive chemotherapy or other therapies for up to 100 days from prophylaxis initiation. SECONDARY OBJECTIVES: I. To evaluate the incidence of invasive aspergillosis (IA) within 100 days of beginning isavuconazole prophylaxis in newly diagnosed patients with AML/MDS receiving intensive chemotherapy or other therapies. II. To evaluate the incidence of other IFIs within 100 days of beginning isavuconazole prophylaxis in newly diagnosed patients with AML/MDS receiving intensive chemotherapy or other therapies. III. To evaluate the composite outcome of treatment success versus (vs.) failure in this patient population. IV. To measure the overall survival (OS) of study participants. V. To measure the IFI-free survival of study participants. VI. To document the time to death from any cause in the study population. VII. To document the time to death related to IFI in the study population. VIII. To document the time to diagnosis of proven or probable IFI in the study population. IX. To document the time to initiation of empiric anti-fungal therapy in the study population. X. To characterize the safety, tolerability and adverse event (AE) profile of isavuconazole in the prophylactic setting. EXPLORATORY OBJECTIVES: I. To assess the potential role, if any, of therapeutic drug monitoring (TDM) of isavuconazole levels in the prophylactic setting in patients with newly diagnosed AML/MDS receiving cytotoxic chemotherapy or other therapies. II. To determine the in vitro susceptibility of agents causing "breakthrough" IFIs to antifungal agents. OUTLINE: Patients receive isavuconazole orally (PO) every 8 hours for 6 doses and then once daily (QD) or intravenously (IV) over 1 hour every 8 hours for 6 doses and then QD for up to 4 days for 12 weeks in the absence of disease progression or unacceptable toxicity.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Neutropenia

Interventions

Type	Name	Description
DRUG	Isavuconazole	Given PO or IV

Timeline

• Start date: 2017-03-28
• Primary completion: 2020-08-10
• Completion: 2020-08-10
• First posted: 2017-01-13
• Last updated: 2021-10-26
• Results posted: 2021-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study