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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-03468 | Other Identifier | NCI/CTRP |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Hydration Regimen | Active Comparator | 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). |
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| Reduced hydration regimen | Experimental | The reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous fluids | Drug | Administration of post HDMTX intravenous fluids (IVF) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cady P Noda, PharmD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39868759 | Derived | Noda 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2019 | Feb 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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The study uses a prospective randomized controlled crossover study design.
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| 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 |
| 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 |
| 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 |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |