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Intravenous fluids for Acute Lymphoblastic Leukemia

Q: Is administering intravenous fluids to patients an innocuous practice?

Our team evaluated the safety of Intravenous fluids to be a 1 because this is an early stage trial, with only preliminary data available outlining its efficacy and risk profile.

Q: What is the current enrollment capacity for this research project?

Indeed, the information on clinicaltrials.gov conveys that this investigation is enrolling participants at present. The trial was initially made available to potential patients on October 2nd 2019 and has been modified most recently on August 25th 2022. There are 24 spots open at a single medical centre.

Q: Am I eligible to join this clinical research project?

In order to be accepted into this clinical experiment, patients must have <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> and fall between 1 Year and 17 years old. The total number of participants needed is 24.

Q: Is this particular research endeavor including elderly individuals as participants?

Based on the outlined requirements for participation, the minimum age of enrolment is 1 year old and the cut-off age for entry into this trial is 17.

Q: Is there still opportunity for enrollment in this experiment?

Clinicaltrials.gov confirms that this research is actively enrolling participants, with the study first appearing on October 2nd 2019 and recently updated on August 25th 2022.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

698 Previous Clinical Trials

22,884,985 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is administering intravenous fluids to patients an innocuous practice?

"Our team evaluated the safety of Intravenous fluids to be a 1 because this is an early stage trial, with only preliminary data available outlining its efficacy and risk profile."

Answered by AI

What is the current enrollment capacity for this research project?

"Indeed, the information on clinicaltrials.gov conveys that this investigation is enrolling participants at present. The trial was initially made available to potential patients on October 2nd 2019 and has been modified most recently on August 25th 2022. There are 24 spots open at a single medical centre."

Answered by AI

Am I eligible to join this clinical research project?

"In order to be accepted into this clinical experiment, patients must have lymphoma and fall between 1 Year and 17 years old. The total number of participants needed is 24."

Answered by AI

Is this particular research endeavor including elderly individuals as participants?

"Based on the outlined requirements for participation, the minimum age of enrolment is 1 year old and the cut-off age for entry into this trial is 17."

Answered by AI

Is there still opportunity for enrollment in this experiment?

"Clinicaltrials.gov confirms that this research is actively enrolling participants, with the study first appearing on October 2nd 2019 and recently updated on August 25th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03964259.