LymphomaPhase 1NCT03964259
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
A Phase 1 study testing Intravenous fluids in people with Lymphoma and Acute Lymphoblastic Leukemia, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer
- What is being tested?
- Intravenous fluids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2019to 28 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond
Richmond, Virginia, 23298
About this study
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
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.
Read the 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.
- Conditions
- Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Pediatric Lymphoma
- Being tested
- Intravenous fluids
- Keywords
- High Dose Methotrexate, HDMTX, Intravenous Fluids
- Medical subject headings
- Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous fluidsDrug
Administration of post HDMTX intravenous fluids (IVF)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Intravenous fluids |
| 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. Receives: Drug: Intravenous fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 63 Days
Secondary outcomes (4)
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.
Measured: 84 Days
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.
Measured: 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.
Measured: 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.
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start2 Oct 2019
- Primary completion7 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study uses a prospective randomized controlled crossover study design.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cady P Noda, PharmD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964259
- Sponsor's protocol ID
- MCC-18-14244
- Other IDs
- NCI-2019-03468
- Status last verified
- Feb 2024
- First submitted
- 23 May 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39868759
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03964259
- Acronym / sponsor ID
- MCC-18-14244
- Conditions
- Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Pediatric Lymphoma
- Keywords
- High Dose Methotrexate, HDMTX, Intravenous Fluids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study uses a prospective randomized controlled crossover study design.
| Arm | Type | Receives |
|---|---|---|
| Standard Hydration Regimen | Active comparator | Drug: Intravenous fluidsIn 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). |
| Reduced hydration regimen | Experimental | Drug: Intravenous fluidsThe reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous fluidsAdministration of post HDMTX intravenous fluids (IVF) | Drug | Reduced hydration regimen, Standard Hydration Regimen |
Primary outcome
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.
4 secondary outcomes
Markers of kidney toxicity
Time frame: 84 Days
Markers of fluid overload
Time frame: 84 Days
Effects on therapy delays
Time frame: 84 Days
Effects on development of severe mucositis
Time frame: 84 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 39868759Noda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cady P Noda, PharmD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous fluids in people with Lymphoma and Acute Lymphoblastic Leukemia, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L (time frame: 63 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.