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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 (Responsible Party):
Adam Esbenshade, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00993694
First received: October 9, 2009
Last updated: April 13, 2017
Last verified: April 2017
  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: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Lymphosarcoma Hodgkin Lymphoma Diffuse Large B-Cell Lymphoma Waldenstrom Macroglobulinemia Multiple Myeloma Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia B-cell Lymphoma Burkitt Lymphoma Myelofibrosis Follicular Lymphoma Marginal Zone Lymphoma Mantle Cell Lymphoma Aplastic Anemia Chronic Myeloid Leukemia Hodgkin Lymphoma, Childhood Primary Central Nervous System Lymphoma Essential Thrombocythemia Lymphoma, Large-cell Anaplastic Large Cell Lymphoma Anaplastic Plasmacytoma Chronic Myeloproliferative Disorders Chronic Myelomonocytic Leukemia Cutaneous T-cell Lymphoma Juvenile Myelomonocytic Leukemia Lymphoblastic Lymphoma Polycythemia Vera AL Amyloidosis Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Mycosis Fungoides Extranodal Nasal NK/T Cell Lymphoma Sezary Syndrome Lymphomatoid Granulomatosis Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Hairy Cell Leukemia Large Granular Lymphocyte Leukemia Aggressive NK Cell Leukemia Myelodysplastic/myeloproliferative Disease Chronic Neutrophilic Leukemia
U.S. FDA Resources

Further study details as provided by Adam Esbenshade, Vanderbilt University:

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
  • Major risk factors for developing methemoglobinemia

Enrollment: 41
Actual Study Start Date: January 2009
Study Completion Date: December 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)
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
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 University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Adam J. Esbenshade, MD Vanderbilt-Ingram Cancer Center
  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
Study First Received: October 9, 2009
Last Updated: April 13, 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

ClinicalTrials.gov processed this record on July 21, 2017