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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
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
- Cancer
- Childhood Cancer
- Pediatric Cancer
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 84 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
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 moreAwards & 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
714 Previous Clinical Trials
22,888,425 Total Patients Enrolled
Cady P Noda, PharmDPrincipal InvestigatorVirginia Commonwealth University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.You have a medical, psychological, or social condition that the researcher thinks may make it harder for you to follow the study requirements or may increase your risk.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Hydration Regimen
- Group 2: Reduced hydration regimen
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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