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Trial record 26 of 325 for:    "Acute Lymphocytic Leukemia" | "Methotrexate"

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

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ClinicalTrials.gov Identifier: NCT03964259
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Lymphoma Acute Lymphoblastic Leukemia Pediatric Cancer Pediatric ALL Pediatric Lymphoma Drug: Intravenous fluids Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study uses a prospective randomized controlled crossover study design.
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : April 30, 2023


Arm Intervention/treatment
Active Comparator: Standard Hydration Regimen
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).
Drug: Intravenous fluids
Administration of post HDMTX intravenous fluids (IVF)

Experimental: Reduced hydration regimen
The reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion.
Drug: Intravenous fluids
Administration of post HDMTX intravenous fluids (IVF)




Primary Outcome Measures :
  1. Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L [ Time Frame: 63 Days ]
    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 :
  1. Markers of kidney toxicity [ Time Frame: 84 Days ]
    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.

  2. Markers of fluid overload [ Time Frame: 84 Days ]
    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.

  3. Effects on therapy delays [ Time Frame: 84 Days ]
    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.

  4. Effects on development of severe mucositis [ Time Frame: 84 Days ]
    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.



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964259


Contacts
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Contact: Cady P Noda, Pharm.D. 804-828-4070 cady.noda@vcuhealth.org
Contact: Lindsey B Gwaltney, RN 804-628-2112 lbgwaltney@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond Recruiting
Richmond, Virginia, United States, 23298
Contact: Lindsey B Gwaltney, RN    804-628-2112    lbgwaltney@vcu.edu   
Contact: Cady P Noda, Pharm.D.    804-828-4070    cady.noda@vcuhealth.org   
Principal Investigator: Cady P Noda, Pharm.D         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Cady P Noda, PharmD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03964259     History of Changes
Other Study ID Numbers: MCC-18-14244
NCI-2019-03468 ( Other Identifier: NCI/CTRP )
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Virginia Commonwealth University:
High Dose Methotrexate
HDMTX
Intravenous Fluids
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Methotrexate
Lymphoma
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors