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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00993694
First received: October 9, 2009
Last updated: November 4, 2010
Last verified: December 2009
History of Changes

October 9, 2009
November 4, 2010
January 2009
December 2009   (final data collection date for primary outcome measure)
  • 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 [ Designated as safety issue: No ]
  • Major risk factors for developing methemoglobinemia [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00993694 on ClinicalTrials.gov Archive Site
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Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With Dapsone
Dapsone Induced Methemoglobinemia in Pediatric Hematologic Malignancy and Aplastic Anemia

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.

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.
Observational
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  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Methemoglobinemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Nonmalignant Neoplasm
  • Drug: chemotherapy
  • Drug: dapsone
  • Other: medical chart review
  • Procedure: assessment of therapy complications
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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December 2009   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00993694
CDR0000652603, VU-VICC-PED-0916, IRB# 090009
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Adam J. Esbenshade, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Adam J. Esbenshade, MD Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP