search
Back to results

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

Primary Purpose

Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravenous fluids
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma focused on measuring High Dose Methotrexate, HDMTX, Intravenous Fluids

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Hydration Regimen

Reduced hydration regimen

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 23, 2019
Last Updated
October 10, 2023
Sponsor
Virginia Commonwealth University
search

1. Study Identification

Unique Protocol Identification Number
NCT03964259
Brief Title
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
December 7, 2022 (Actual)
Study Completion Date
December 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Pediatric Lymphoma
Keywords
High Dose Methotrexate, HDMTX, Intravenous Fluids

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
The study uses a prospective randomized controlled crossover study design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Hydration Regimen
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Reduced hydration regimen
Arm Type
Experimental
Arm Description
The reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion.
Intervention Type
Drug
Intervention Name(s)
Intravenous fluids
Intervention Description
Administration of post HDMTX intravenous fluids (IVF)
Primary Outcome Measure Information:
Title
Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L
Description
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.
Time Frame
63 Days
Secondary Outcome Measure Information:
Title
Markers of kidney toxicity
Description
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.
Time Frame
84 Days
Title
Markers of fluid overload
Description
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.
Time Frame
84 Days
Title
Effects on therapy delays
Description
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.
Time Frame
84 Days
Title
Effects on development of severe mucositis
Description
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.
Time Frame
84 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cady P Noda, PharmD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs