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NCT02133599 · ClinicalTrials.gov registry record · NA
Prediction of Excretion and Toxicity of High Dose Methotrexate in Children and Adolescents With ALL
A NA study of ALL, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT02133599: Completed NA study of ALL, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT02133599 is a NA study of ALL that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 23 participants, below the 960-participant average among 13 other ALL trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02133599, a NA study of ALL, has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
Each year approximately 2,900 children and adolescents less than 20 years old are diagnosed with acute lymphoblastic leukemia or acute lymphoblastic lymphoma in the United States. (For the purposes of this protocol, ALL will be used to refer to patients with either acute lymphoblastic leukemia or acute lymphoblastic lymphoma as patients are treated in the same manner.) High-dose methotrexate (HDMTX; 5 g/m2) remains an important component of standard treatment for most ALL patients. However, high plasma and intracellular MTX concentrations (defined as a MTX level of \>1 µmol/L at 42 hours and \> 0.40 µmol/L at 48 hours) can quickly lead to acute kidney, bone marrow, liver, skin, central nervous system, and gastrointestinal toxicities requiring extended hospitalization and delays in subsequent chemotherapy treatments. This study seeks to identify more sensitive markers of kidney injury that could serve as better predictors of delayed excretion and/or toxicity of HDMTX. This study is a pilot repeated-measures feasibility study. Hypothesis 1: Directly measured GFR (mGFR, a type of test to measure the filtering rate of kidneys) by iohexol clearance obtained prior to HDMTX will demonstrate greater sensitivity and specificity for prediction of delayed MTX excretion and/or toxicity in children and adolescents with ALL than serum creatinine (sCr) alone or sCr used for eGFR calculation. If this study proves that mGFR is a better predictor of delayed MTX excretion and/or toxicity, then another study will be developed in the future to determine if modifying the HDMTX dose or adjusting supportive care based on mGFR will prevent delayed clearance and toxicity without impacting patient survival. Hypothesis 2: Those participants prospectively demonstrating delayed MTX excretion or toxicity will exhibit elevation of kidney injury biomarkers less than 24 hours following initiation of HDMTX infusion compared to pre-chemotherapy measurements. These biomarkers will increase prior to
Primary Outcome
A change from baseline Iohexol clearance results after about six weeks
Conditions Studied
Interventions
- DRUG IOHEXOL
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hosptial of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-07-24 |
| Est. Completion | 2019-02-27 |
| Phase | NA |
What the finished NCT02133599 record still lists
NCT02133599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 960-participant average among 13 other ALL trials with a reported enrollment target (98% lower).
The record links to 1 condition, with ALL appearing as the primary indexed condition, and to 1 intervention - of which IOHEXOL is the first listed.
NCT02133599 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02133599 about?
NCT02133599 is a clinical study titled "Prediction of Excretion and Toxicity of High Dose Methotrexate in Children and Adolescents With ALL". Each year approximately 2,900 children and adolescents less than 20 years old are diagnosed with acute lymphoblastic leukemia or acute lymphoblastic lymphoma in the United States. (For the purposes of this protocol, ALL will be used to refer to patients with either acute lymphoblastic leukemia or ac...
What is the current status of trial NCT02133599?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2014-07-24. Estimated completion is 2019-02-27.
What conditions does trial NCT02133599 study?
This clinical trial studies the following conditions: ALL.
What interventions are being tested in trial NCT02133599?
The interventions under investigation include: IOHEXOL (DRUG).
Who is sponsoring clinical trial NCT02133599?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02133599 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ALL
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02133599's enrollment target sits among peer trials
23 12th of 13 higher than 1 of 13 other ALL trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ALL trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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