Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia

Launched by WEST VIRGINIA UNIVERSITY · Sep 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Xerava™ (eravacycline) to help prevent infections in patients with blood cancers, such as leukemia, who are undergoing treatment that lowers their immune system. These patients often experience a condition called neutropenia, which means they have very low levels of a type of white blood cell that helps fight infections. The goal of the trial is to see how well eravacycline works in protecting these patients from infections during their treatment period.

To join the study, participants must be undergoing specific types of chemotherapy for acute leukemia or preparing for a stem cell transplant. They also need to be able to give their consent and meet certain health criteria. Throughout the trial, participants will be monitored for any infections that occur while they are taking eravacycline. This study is important because it may offer a new way to protect vulnerable patients from serious infections during a critical time in their treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All patients receiving induction chemotherapy for treatment of acute leukemia or receiving preparative regimen for HSCT
• • Patient must provide informed consent.
• • Bilirubin ≤ 3 x the ULN and AST/ALT ≤ 5 x ULN
• Exclusion Criteria:
• • Uncontrolled bacterial, viral or fungal infection at the time of study enrollment.
• • Urinary tract infection receiving active treatment
• • Acute pancreatitis (not necessary to work-up unless symptomatic)
• • History of known hypersensitivity to eravacycline, tetracycline, doxycycline, minocycline, tigecycline, sarecycline, oxytetracycline, or omadacycline
• • Pseudomonas infection within 30 days prior to study enrollment
• • Receiving strong inhibitors or inducers of cytochrome P450 3A4 will be excluded from the study (see Appendix B for complete list of medications)
• • Pregnant or lactating women