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Trial record 10 of 325 for:    "Acute Lymphocytic Leukemia" | "Methotrexate"

Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00993135
Recruitment Status : Completed
First Posted : October 12, 2009
Last Update Posted : April 10, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment
Leukemia Renal Toxicity Drug: methotrexate Other: medical chart review Procedure: assessment of therapy complications

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Renal Dysfunction With Low to Intermediate Dose Methotrexate in Acute Lymphoblastic Leukemia Treatment
Study Start Date : December 2008
Actual Primary Completion Date : December 2009

Primary Outcome Measures :
  1. Incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of acute lymphoblastic leukemia

    • Receiving low- to intermediate-dose methotrexate or received treatment (chemotherapy and/or radiation) at Vanderbilt Children's Hospital


  • Not specified


  • See Disease Characteristics

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 identifier (NCT number): NCT00993135

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United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University Medical Center
National Cancer Institute (NCI)
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Principal Investigator: Pinki Prasad, MD Vanderbilt-Ingram Cancer Center

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Responsible Party: Vanderbilt University Medical Center Identifier: NCT00993135     History of Changes
Other Study ID Numbers: CDR0000652517
P30CA068485 ( U.S. NIH Grant/Contract )
IRB# 081330
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanderbilt University Medical Center:
renal toxicity
childhood acute lymphoblastic leukemia
adult acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors