Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-29 @ 4:11 AM
Study NCT ID:
NCT00993135
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2009-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Renal Dysfunction With Low to Intermediate Dose Methotrexate in Acute Lymphoblastic Leukemia Treatment
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Gathering information about how often kidney dysfunction occurs in children and young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This research study is looking at kidney dysfunction in children and young adults who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic leukemia.
PURPOSE: This research study is looking at kidney dysfunction in children and young adults who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic leukemia.
Detailed Description:
OBJECTIVES:
* Examine the incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate.
OUTLINE: Medical charts are reviewed to obtain the following information: gender, age, diagnosis, regimen, day of therapy, renal function, creatinine level, mucositis, skin sloughing, methotrexate level at highest level, and number of days after intravenous methotrexate.
* Examine the incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate.
OUTLINE: Medical charts are reviewed to obtain the following information: gender, age, diagnosis, regimen, day of therapy, renal function, creatinine level, mucositis, skin sloughing, methotrexate level at highest level, and number of days after intravenous methotrexate.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |
| VU-VICC-PED-0913 | None | None | View | |
| IRB# 081330 | None | None | View |