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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
  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 Neoplasms
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:

Drug Information available for: Dapsone
Genetic and Rare Diseases Information Center resources: Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Acute Lymphoblastic Leukemia Lymphosarcoma Follicular Lymphoma Polycythemia Vera Essential Thrombocythemia Myelodysplastic Syndromes Multiple Myeloma Lymphoma, Large-cell B-cell Lymphoma Myelofibrosis Chronic Myelomonocytic Leukemia Chronic Myeloid Leukemia Burkitt Lymphoma Childhood Acute Lymphoblastic Leukemia Anaplastic Large Cell Lymphoma Diffuse Large B-Cell Lymphoma Mantle Cell Lymphoma Hodgkin Lymphoma Mycosis Fungoides Hairy Cell Leukemia Cutaneous T-cell Lymphoma Lymphoblastic Lymphoma Chronic Myeloproliferative Disorders Aplastic Anemia Large Granular Lymphocyte Leukemia Aggressive NK Cell Leukemia Primary Central Nervous System Lymphoma Sezary Syndrome Waldenstrom Macroglobulinemia AL Amyloidosis Myelodysplastic/myeloproliferative Disease Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Juvenile Myelomonocytic Leukemia Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hodgkin Lymphoma, Childhood Anaplastic Plasmacytoma Lymphomatoid Granulomatosis Chronic Neutrophilic Leukemia
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
Primary Completion Date: December 2009 (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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Adam J. Esbenshade, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Adam J. Esbenshade, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00993694     History of Changes
Other Study ID Numbers: CDR0000652603  VU-VICC-PED-0916  IRB# 090009 
Study First Received: October 9, 2009
Last Updated: November 4, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
methemoglobinemia
aplastic anemia
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
atypical chronic myeloid leukemia, BCR-ABL negative
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:
Lymphoma
Disease
Leukemia
Syndrome
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms
Anemia
Myelodysplastic Syndromes
Preleukemia
Anemia, Aplastic
Myeloproliferative Disorders
Plasmacytoma
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
 Methemoglobinemia
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on September 26, 2016