Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With Dapsone - Full Text View

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00993694

Purpose

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.

Condition	Intervention
Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Methemoglobinemia Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Nonmalignant Neoplasm	Drug: chemotherapy Drug: dapsone Other: medical chart review Procedure: assessment of therapy complications

Study Type:	Observational
Official Title:	Dapsone Induced Methemoglobinemia in Pediatric Hematologic Malignancy and Aplastic Anemia

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia methemoglobinemia, beta-globin type transthyretin amyloidosis

MedlinePlus related topics: Anemia Cancer Fungal Infections Hodgkin Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma

Drug Information available for: Dapsone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	January 2009
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993694

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Adam Esbenshade 615-936-1762
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Adam J. Esbenshade, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Vanderbilt-Ingram Cancer Center ( Adam J. Esbenshade )
Study ID Numbers:	CDR0000652603, VU-VICC-PED-0916, IRB# 090009
Study First Received:	October 9, 2009
Last Updated:	January 28, 2010
ClinicalTrials.gov Identifier:	NCT00993694 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

methemoglobinemia
aplastic anemia
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
juvenile myelomonocytic leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment

prolymphocytic leukemia
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
T-cell large granular lymphocyte leukemia
AIDS-related diffuse large cell lymphoma
AIDS-related diffuse mixed cell lymphoma

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Blood Protein Disorders
Paraproteinemias
Hemostatic Disorders
Anti-Bacterial Agents
Antimalarials
Leukemia
Antiparasitic Agents
Preleukemia
Hemorrhagic Disorders
Pathologic Processes
Therapeutic Uses

Syndrome
Anemia, Aplastic
Dapsone
Cardiovascular Diseases
Lymphoma
Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Anemia
Vascular Diseases
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010