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

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 1

Conditions: Pediatric Lymphoma; Pediatric ALL; Lymphoma; Pediatric Cancer; Acute Lymphoblastic Leukemia

Treatments: Drug: Intravenous fluids

Study type: Interventional

Funder types: Other

Identifiers

NCT03964259

MCC-18-14244

NCI-2019-03468 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Standard Hydration Regimen

Active Comparator group

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).

Treatment:

Drug: Intravenous fluids

Reduced hydration regimen

Experimental group

Description:

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

Treatment:

Drug: Intravenous fluids