Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acu… (NCT03019939) | Clinical Trial Compass
CompletedPhase 2
Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia
United States65 participantsStarted 2017-03-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with either newly diagnosed AML or MDS who have either begun (within 4 days of starting study drug) or are planned to begin specific treatment for their AML/MDS; hydroxyurea and cytarabine used for cytoreduction while awaiting initiation of definitive therapy are not considered "specific" treatment; patients who are participating in other therapeutic clinical trials for their AML/MDS may participate in this trial
* Patients must have or be anticipated to have neutropenia (absolute neutrophil count \[ANC\] \< 0.5 x 10\^9/L) (75) for \>= 7 days as a result of treatment of their AML/MDS
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Total bilirubin =\< 3 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 5 x ULN
* Patients must be able to take oral medications, although a brief period of IV therapy (\< 4 days) is permitted at trial entry
* Patients must be willing and able to provide written informed consent for the trial
* Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception; effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization
* Postmenopausal women must be …
What they're measuring
1
Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)
Timeframe: Up to 100 days from prophylaxis initiation