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出境医 / 临床实验 / Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
Study Description
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.
Study Design
| 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 |
Arms and Interventions
| 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)
|
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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)
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| 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
| 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
| Principal Investigator: | Cady P Noda, PharmD | Virginia Commonwealth University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 23, 2019 | ||||||||
| First Posted Date ICMJE | May 28, 2019 | ||||||||
| Last Update Posted Date | September 21, 2020 | ||||||||
| Actual Study Start Date ICMJE | October 2, 2019 | ||||||||
| Estimated Primary Completion Date | January 15, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia | ||||||||
| Official Title ICMJE | Pilot Study on the Reduced Intravenous Fluids to Improve Clearance of High-Dose Methotrexate (HDMTX) in Children With Lymphoma or Acute Lymphoblastic Leukemia | ||||||||
| 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. | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Intravenous fluids
Administration of post HDMTX intravenous fluids (IVF)
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
24 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 30, 2023 | ||||||||
| Estimated Primary Completion Date | January 15, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 1 Year to 17 Years (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03964259 | ||||||||
| Other Study ID Numbers ICMJE | MCC-18-14244 NCI-2019-03468 ( Other Identifier: NCI/CTRP ) |
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| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Virginia Commonwealth University | ||||||||
| Study Sponsor ICMJE | Virginia Commonwealth University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Virginia Commonwealth University | ||||||||
| Verification Date | September 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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