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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Lymphoma; Methemoglobinemia; Nonmalignant Neoplasm

Intervention: polymorphism analysis (Genetic); laboratory biomarker analysis (Other); medical chart review (Other); assessment of therapy complications (Procedure)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Vanderbilt-Ingram Cancer Center

Official(s) and/or principal investigator(s):
Adam J. Esbenshade, MD, Principal Investigator, Affiliation: Vanderbilt-Ingram Cancer Center
Kathleen M. Von Wahlde, Affiliation: Vanderbilt-Ingram Cancer Center


RATIONALE: Gathering information about patients with childhood hematologic cancer or aplastic anemia treated with dapsone may help doctors learn more about risk factors for developing methemoglobinemia. PURPOSE: This phase I trial is studying methemoglobinemia in patients with childhood hematologic cancer or aplastic anemia treated with dapsone.

Clinical Details

Official title: Dapsone Induced Methemoglobinemia Study (DIMS)

Study design: N/A

Primary outcome:

Age, sex, and body mass index as host-related risk factors for developing symptomatic methemoglobinemia

Cytochrome b5 reductase levels

Detailed description: OBJECTIVES: Primary

- Determine host-related risk factors for developing symptomatic methemoglobinemia in

patients with pediatric hematologic malignancies or aplastic anemia who received dapsone prophylaxis for pneumocystis carinii.

- Determine whether a deficiency in cytochrome b5 reductase is a risk factor for

symptomatic methemoglobinemia in a subset of these patients. Secondary

- Collect a genomic DNA specimen from a subset of patients for whom enzyme testing is

being conducted to store for future analyses of variations in the genes responsible for cytochrome b5 reductase. OUTLINE: Patients' medical records are reviewed for possible risk factors (e. g., age, sex, and body mass index) for developing symptomatic methemoglobinemia. A subset of patients undergo blood sample collection for analysis of cytochrome b5 reductase levels. DNA samples are also collected from these patients for future genetic polymorphism studies.


Minimum age: N/A. Maximum age: 22 Years. Gender(s): Both.



- Diagnosis of hematologic malignancy or aplastic anemia within the past 15 years at

the Division of Pediatric Hematology/Oncology at Vanderbilt University

- Previously treated with dapsone as prophylaxis for pneumocystis carinii

- May or may not have symptomatic methemoglobinemia


- Not specified


- Not specified

Locations and Contacts

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States

Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville, Tennessee 37064, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2009
Last updated: May 28, 2010

Page last updated: August 20, 2015

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