⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT03019939

Interventions

Isavuconazole

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

M D Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Prithviraj Bose

Affiliation: M.D. Anderson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: