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

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ClinicalTrials.gov Identifier: NCT00993694
Recruitment Status : Completed
First Posted : October 12, 2009
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Adam Esbenshade, Vanderbilt University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
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

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.


Study Design
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Study Type : Observational
Actual Enrollment : 41 participants
Official Title: Dapsone Induced Methemoglobinemia in Pediatric Hematologic Malignancy and Aplastic Anemia
Actual Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Dapsone
Genetic and Rare Diseases Information Center resources: Multiple Myeloma Waldenstrom Macroglobulinemia Lymphosarcoma Hodgkin Lymphoma Mantle Cell Lymphoma B-cell Lymphoma Lymphoma, Large-cell Anaplastic Large Cell Lymphoma Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia Burkitt Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Hairy Cell Leukemia Follicular Lymphoma Diffuse Large B-Cell Lymphoma Hodgkin Lymphoma, Childhood AL Amyloidosis Marginal Zone Lymphoma Primary Central Nervous System Lymphoma Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Cutaneous T-cell Lymphoma Chronic Myeloid Leukemia Myelofibrosis Chronic Myeloproliferative Disorders Mycosis Fungoides Polycythemia Vera Essential Thrombocythemia Myelodysplastic/myeloproliferative Disease Aplastic Anemia Sezary Syndrome Lymphoblastic Lymphoma Extranodal Nasal NK/T Cell Lymphoma Plasmacytoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Large Granular Lymphocyte Leukemia Aggressive NK Cell Leukemia Lymphomatoid Granulomatosis Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Neutrophilic Leukemia
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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
  2. Major risk factors for developing methemoglobinemia

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Adam J. Esbenshade, MD Vanderbilt-Ingram Cancer Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Adam Esbenshade, Assistant Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00993694     History of Changes
Obsolete Identifiers: NCT00960050
Other Study ID Numbers: CDR0000652603
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-PED-0916
IRB# 090009
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

Keywords provided by Adam Esbenshade, Vanderbilt University:
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
Syndrome
Leukemia
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
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