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Intravenous fluids for 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

Study Summary

This trial is testing if a reduced volume of hydration given intravenously will cause the body to clear methotextrate faster than the standard amount of hydration.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Lymphoma
  • Pediatric 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

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

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
700 Previous Clinical Trials
22,886,763 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 May 2025
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