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Completed

NCT Number: NCT00993135

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

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Renal Toxicity

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

methotrexate

Drug

medical chart review

Other

assessment of therapy complications

Procedure

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Renal Dysfunction With Low to Intermediate Dose Methotrexate in Acute Lymphoblastic Leukemia Treatment

Important dates

Study start
2008
Primary completion
2009
First posted
Oct 12, 2009
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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