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

Lymphoma Clinical Trial

Official title:

Dapsone Induced Methemoglobinemia in Pediatric Hematologic Malignancy and Aplastic Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993694
• Other study ID #: CDR0000652603
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: October 9, 2009
• Last updated: April 13, 2017
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00960050

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Chronic Myeloproliferative Disorders
• Disease
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Methemoglobinemia
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Nonmalignant Neoplasm
• Plasmacytoma
• Preleukemia
• Syndrome

Intervention

Drug:
• chemotherapy

• dapsone

Other:
• medical chart review

Procedure:
• assessment of therapy complications

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Major risk factors for developing methemoglobinemia