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NCT Number: NCT03964259

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

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.

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Key information

Conditions

Lymphoma Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Pediatric Cancer Pediatric Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Richmond, Virginia, 23298, United States

About this study

This study uses a prospective randomized controlled crossover study design. Neither patients nor clinicians are blinded to the standard versus reduced intravenous fluids (IVF) regimen. Patients are randomized to begin with standard volume or reduced volume IVF. Over the course of 4 cycles of High Dose Methotrexate (HDMTX), patients alternate between standard and reduced volume post hydration fluids protocols.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Intravenous fluids

Drug

Administration of post HDMTX intravenous fluids (IVF)

Primary outcomes

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

    Time frame: 63 Days

    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.

Secondary outcomes

  1. Markers of kidney toxicity

    Time frame: 84 Days

    To determine the effect of a reduced volume hydration regimen on markers of kidney toxicity (nephrotoxicity) by evaluating serum creatinine levels from baseline levels as well as the maximum decrease in estimated glomerular filtration rate (GFR) utilizing the modified Schwartz equation, following each HDMTX cycle.

  2. Markers of fluid overload

    Time frame: 84 Days

    To determine the effect of a reduced volume hydration regimen on markers of fluid overload by evaluating maximum weight gain during each hospitalization, and by evaluating the incidence of NCI Common Terminology Criteria for Adverse Events (CTCAE) version v5.0 ≥ grade 1 clinical sequelae of hydration such as facial edema, pulmonary edema, abdominal distension, extremity edema, and weight gain.

  3. Effects on therapy delays

    Time frame: 84 Days

    To examine the effects of a reduced volume hydration regimen on treatment schedule by measuring the number of days subsequent therapy is delayed for reasons other than scheduling issues or preferences.

  4. Effects on development of severe mucositis

    Time frame: 84 Days

    To examine the effects of a reduced volume hydration regimen on development of severe mucositis by measuring the incidence of grade ≥ 3 (CTCAE v5.0) mucositis.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Pilot Study on the Reduced Intravenous Fluids to Improve Clearance of High-Dose Methotrexate (HDMTX) in Children With Lymphoma or Acute Lymphoblastic Leukemia

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 28, 2019
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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