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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964259
• Other study ID #: MCC-18-14244
• Secondary ID: NCI-2019-03468
• Status: Completed
• Phase: Phase 1
• Start date: October 2, 2019
• Est. completion date: December 28, 2022

Study information

• Verified date: February 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 28, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Pediatric ALL
• Pediatric Cancer
• Pediatric Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Intravenous fluids
Administration of post HDMTX intravenous fluids (IVF)

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Markers of kidney toxicity	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.	84 Days
Secondary	Markers of fluid overload	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.	84 Days
Secondary	Effects on therapy delays	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.	84 Days
Secondary	Effects on development of severe mucositis	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.	84 Days