Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03149055|
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancy Myeloproliferative Disorder||Drug: Isavuconazole||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center, Open-label Trial of Isavuconazole Prophylaxis Against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)|
|Actual Study Start Date :||May 4, 2017|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Isavuconazole prophylaxis
Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician.
Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose.
Other Name: Isavuconazonium sulfate
- To evaluate the clinical failure rate by week + 14 post HCT of isavuconazole prophylaxis per protocol . [ Time Frame: 14 weeks ]
Clinical failure is measured by:
- Systemic antifungal therapy for > 14 consecutive days for suspected fungal infection up to week 14.
- Breakthrough proven or probable fungal infection during the prophylaxis phase. The prophylaxis phase is defined as the period from the first dose of isavuconazole through 7 days after discontinuation
- Toxicity leading to permanent discontinuation of prophylaxis
- Adverse event requiring discontinuation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149055
|Contact: Genovefa Papanicolaou, MDfirstname.lastname@example.org|
|Contact: Yeon Joo Lee, MD||212-639-8180|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Genovefa Papanicolaou, MD 212-639-8361|