Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With Dapsone

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT00993694
Collaborator
National Cancer Institute (NCI) (NIH)
41
2
11
20.5
1.9

Study Details

Study Description

Brief Summary

RATIONALE: Gathering information about how often methemoglobinemia occurs in young patients receiving dapsone for hematologic cancer or aplastic anemia may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This research study is looking at methemoglobinemia in young patients with hematologic cancer or aplastic anemia treated with dapsone.

Detailed Description

OBJECTIVES:
  • Define the incidence of methemoglobinemia in patients with hematologic malignancy or aplastic anemia who received dapsone prophylaxis through a retrospective chart review encompassing the last 15 years.

  • Identify major risk factors for developing methemoglobinemia.

OUTLINE: Medical charts are reviewed. Of particular interest is demographic information, reasons for beginning dapsone prophylaxis, duration of dapsone prophylaxis, dapsone dosing, methemoglobin level, and treatment with methylene blue.

Study Design

Study Type:
Observational
Actual Enrollment :
41 participants
Official Title:
Dapsone Induced Methemoglobinemia in Pediatric Hematologic Malignancy and Aplastic Anemia
Actual Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Incidence of methemoglobinemia in patients with hematologic malignancy or aplastic anemia who received dapsone prophylaxis through a retrospective chart review encompassing the last 15 years []

  2. Major risk factors for developing methemoglobinemia []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Diagnosis of hematologic malignancy or aplastic anemia

  • Treated within the past 15 years with dapsone prophylaxis during treatment of primary disease

PATIENT CHARACTERISTICS:
  • Not specified
PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt-Ingram Cancer Center - Cool Springs Nashville Tennessee United States 37064
2 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838

Sponsors and Collaborators

  • Vanderbilt University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Adam J. Esbenshade, MD, Vanderbilt-Ingram Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adam Esbenshade, Assistant Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00993694
Other Study ID Numbers:
  • CDR0000652603
  • P30CA068485
  • VU-VICC-PED-0916
  • IRB# 090009
  • NCT00960050
First Posted:
Oct 12, 2009
Last Update Posted:
Apr 17, 2017
Last Verified:
Apr 1, 2017
Keywords provided by Adam Esbenshade, Assistant Professor of Pediatrics, Vanderbilt University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 17, 2017