Clinical trial · Interventional
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
Pilot Study on the Reduced Intravenous Fluids to Improve Clearance of High-Dose Methotrexate (HDMTX) in Children With Lymphoma or Acute Lymphoblastic Leukemia
NCT03964259CI-TRIAL-00073966completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Pediatric Lymphoma | Childhood Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous fluids | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Hydration Regimen
- 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).
- interventionNames
- Drug: Intravenous fluids
- type
- EXPERIMENTAL
- label
- Reduced hydration regimen
- description
- The reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion.
- interventionNames
- Drug: Intravenous fluids
Primary outcomes (1)
- measure
- Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNoda C, Gwaltney L, Sabo R, Lo M, Schefft M. Standard Versus Reduced Hydration to Improve Elimination of High-Dose Methotrexate in Pediatric Patients: A Controlled Crossover Trial. Pediatr Blood Cancer. 2025 Apr;72(4):e31566. doi: 10.1002/pbc.31566. Epub 2025 Jan 27. PMID 39868759