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

Phase 1
Waitlist Available
Led By Cady P Noda, PharmD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if giving patients less fluid through an IV after a high dose of methotrexate can help clear the drug faster compared to the usual amount of fluid. It targets patients who receive high doses of methotrexate and need effective hydration to remove the drug from their system. The study alternates between different fluid amounts to see which works better. Methotrexate is a cytotoxic agent used to treat several malignancies, and its clearance can be influenced by hydration levels.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Pediatric Cancer
  • Lymphoma
  • Childhood Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L
Secondary study objectives
Effects on development of severe mucositis
Effects on therapy delays
Markers of fluid overload
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reduced hydration regimenExperimental Treatment1 Intervention
The reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion.
Group II: Standard Hydration RegimenActive Control1 Intervention
In the standard intravenous fluid (IVF) protocol, following completion of HDMTX infusion, post HDMTX IVF will be initiated at 125 mL/m2/hr (no maximum mL/hr total rate).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intravenous fluids
2015
Completed Phase 1
~460

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
719 Previous Clinical Trials
22,895,826 Total Patients Enrolled
Cady P Noda, PharmDPrincipal InvestigatorVirginia Commonwealth University

Media Library

Intravenous fluids (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03964259 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Standard Hydration Regimen, Reduced hydration regimen
Acute Lymphoblastic Leukemia Clinical Trial 2023: Intravenous fluids Highlights & Side Effects. Trial Name: NCT03964259 — Phase 1
Intravenous fluids (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03964259 — Phase 1
~2 spots leftby Dec 2025