NCT03964259

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 2, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

May 23, 2019

Last Update Submit

February 8, 2024

Conditions

LymphomaAcute Lymphoblastic LeukemiaPediatric CancerPediatric ALLPediatric Lymphoma

Keywords

High Dose MethotrexateHDMTXIntravenous Fluids

Outcome Measures

Primary Outcomes (1)

  • Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L

    To determine whether a reduced volume hydration regimen will lead to a shorter time to methotrexate clearance when compared to a standard IV hydration regimen by measuring serum methotrexate levels twenty-four hours following the end of the high dose methotrexate ( HDMTX) infusion, and continuing every twelve hours until the methotrexate level is less than 0.1 micromol/L.

    63 Days

Secondary Outcomes (4)

  • Markers of kidney toxicity

    84 Days

  • Markers of fluid overload

    84 Days

  • Effects on therapy delays

    84 Days

  • Effects on development of severe mucositis

    84 Days

Study Arms (2)

Standard Hydration Regimen

ACTIVE COMPARATOR

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).

Drug: Intravenous fluids

Reduced hydration regimen

EXPERIMENTAL

The reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion.

Drug: Intravenous fluids

Interventions

Intravenous fluidsDRUG

Administration of post HDMTX intravenous fluids (IVF)

Reduced hydration regimenStandard Hydration Regimen

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of lymphoma or acute lymphoblastic leukemia
  • Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
  • Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
  • Patients of childbearing potential must have a negative pregnancy test (serum or urine)
  • Lactating female patients must agree not to nurse a child while on this trial
  • All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable

You may not qualify if:

  • Trisomy 21
  • History of dialysis within 30 days prior to study registration or currently on dialysis
  • Polyuric renal dysfunction
  • Pregnancy
  • Known or suspected pleural effusion
  • Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Noda C, Gwaltney L, Sabo R, Lo M, Schefft M. Standard Versus Reduced Hydration to Improve Elimination of High-Dose Methotrexate in Pediatric Patients: A Controlled Crossover Trial. Pediatr Blood Cancer. 2025 Apr;72(4):e31566. doi: 10.1002/pbc.31566. Epub 2025 Jan 27.

    PMID: 39868759DERIVED

MeSH Terms

Conditions

LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic Diseases

Study Officials

  • Cady P Noda, PharmD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: The study uses a prospective randomized controlled crossover study design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 28, 2019

Study Start

October 2, 2019

Primary Completion

December 7, 2022

Study Completion

December 28, 2022

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)