Spots Global Cancer Trial Database for Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
Official Title: Pilot Study on the Reduced Intravenous Fluids to Improve Clearance of High-Dose Methotrexate (HDMTX) in Children With Lymphoma or Acute Lymphoblastic Leukemia
Study ID: NCT03964259
Interventions
Study Description
Brief Summary: To determine whether a reduced volume hydration regimen will lead to a shorter time to methotrexate clearance when compared to a standard intravenous (IV) hydration regimen.
Detailed Description: This study uses a prospective randomized controlled crossover study design. Neither patients nor clinicians are blinded to the standard versus reduced intravenous fluids (IVF) regimen. Patients are randomized to begin with standard volume or reduced volume IVF. Over the course of 4 cycles of High Dose Methotrexate (HDMTX), patients alternate between standard and reduced volume post hydration fluids protocols.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond, Richmond, Virginia, United States
Contact Details
Name: Cady P Noda, PharmD
Affiliation: Virginia Commonwealth University
Role: PRINCIPAL_INVESTIGATOR
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