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NCT03964259

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

Completed Phase 1 Last updated 13 February 2024
What this trial tests

Phase 1 trial testing Intravenous fluids in Lymphoma in 10 participants. Completed in 28 December 2022.

Timeline
2 October 2019
Primary endpoint
7 December 2022
28 December 2022

Quick facts

Lead sponsorVirginia Commonwealth University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposesupportive care
Enrollment10
Start date2 October 2019
Primary completion7 December 2022
Estimated completion28 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Virginia Commonwealth University

Who can join

Adults 1 to 17, any sex, with Lymphoma or Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To determine whether a reduced volume hydration regimen will lead to a shorter time to methotrexate clearance when compared to a standard intravenous (IV) hydration regimen.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Standard Versus Reduced Hydration to Improve Elimination of High-Dose Methotrexate in Pediatric Patients: A Controlled Crossover Trial.
    Noda C, Gwaltney L, Sabo R, Lo M, et al · · 2025 · cited 1× · PMID 39868759 · DOI 10.1002/pbc.31566

Verify or expand the search:

Other trials of Intravenous fluids

Trials testing the same drug.

Other recruiting trials for Lymphoma

Currently open trials in the same condition.

Other Virginia Commonwealth University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03964259.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing