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Dapsone Induced Methemoglobinemia Study (DIMS)


Phase 1
N/A
22 Years
Open (Enrolling)
Both
Leukemia, Lymphoma, Methemoglobinemia, Nonmalignant Neoplasm

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Trial Information

Dapsone Induced Methemoglobinemia Study (DIMS)


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Adam J. Esbenshade, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000651820

NCT ID:

NCT00960050

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Methemoglobinemia
  • Nonmalignant Neoplasm
  • methemoglobinemia
  • aplastic anemia
  • childhood acute lymphoblastic leukemia
  • childhood acute myeloid leukemia/other myeloid malignancies
  • childhood chronic myelogenous leukemia
  • juvenile myelomonocytic leukemia
  • childhood Hodgkin lymphoma
  • childhood large cell lymphoma
  • childhood lymphoblastic lymphoma
  • childhood small noncleaved cell lymphoma
  • childhood anaplastic large cell lymphoma
  • childhood diffuse large cell lymphoma
  • childhood grade III lymphomatoid granulomatosis
  • childhood immunoblastic large cell lymphoma
  • childhood nasal type extranodal NK/T-cell lymphoma
  • childhood myelodysplastic syndromes
  • Anemia, Aplastic
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Methemoglobinemia

Name

Location
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool Springs Nashville, Tennessee  37064