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

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Methotrexate

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