NCT03964259

Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia

Pilot Study on the Reduced Intravenous Fluids to Improve Clearance of High-Dose Methotrexate (HDMTX) in Children With Lymphoma or Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma
• Acute Lymphoblastic Leukemia
• Pediatric Cancer
• Pediatric ALL
• Pediatric Lymphoma

Interventions

Type	Name	Description
DRUG	Intravenous fluids	Administration of post HDMTX intravenous fluids (IVF)

Timeline

• Start date: 2019-10-02
• Primary completion: 2022-12-07
• Completion: 2022-12-28
• First posted: 2019-05-28
• Last updated: 2024-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study