Intravenous fluids for Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Lymphoblastic Leukemia+4 MoreIntravenous fluids - Drug
Eligibility
1 - 17
All Sexes
What conditions do you have?
Select

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
  • Acute Lymphoblastic Leukemia (ALL) in Children.
  • Pediatric Lymphoma
  • Lymphoma
  • Pediatric Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 84 Days

63 Days
Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L
84 Days
Effects on development of severe mucositis
Effects on therapy delays
Markers of fluid overload
Markers of kidney toxicity

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard Hydration Regimen
1 of 2
Reduced hydration regimen
1 of 2

Active Control

Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Intravenous fluids · No Placebo Group · Phase 1

Reduced hydration regimen
Drug
Experimental Group · 1 Intervention: Intravenous fluids · Intervention Types: Drug
Standard Hydration Regimen
Drug
ActiveComparator Group · 1 Intervention: Intravenous fluids · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intravenous fluids
2015
N/A
~450

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 84 days

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
624 Previous Clinical Trials
355,770 Total Patients Enrolled
Cady P Noda, PharmDPrincipal InvestigatorVirginia Commonwealth University

Eligibility Criteria

Age 1 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The doctor will order tests to determine if the person has lymphoma or acute lymphoblastic leukemia
You must provide written informed consent, with assent provided if applicable.
The text says that the candidate needs to receive a minimum of 2 cycles of HDMTX
Creatinine clearance ≥ 65 mL/min by modified Schwartz equation.
before starting therapy with INCIVEK Before starting therapy with INCIVEK, all patients of childbearing potential must have a negative pregnancy test (serum or urine).
medication Women who are breastfeeding must not take this medication.