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Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With Dapsone
This study has been completed.
Sponsor:
Vanderbilt University
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
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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:
Genetics Home Reference related topics:
multiple myeloma
Drug Information available for:
Dapsone
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
Myelodysplastic Syndromes
Myelofibrosis
Chronic Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Polycythemia Vera
Chronic Myeloproliferative Disorders
Essential Thrombocythemia
Myelodysplastic/myeloproliferative Disease
Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia
Burkitt Lymphoma
Multiple Myeloma
Lymphosarcoma
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
Mycosis Fungoides
Marginal Zone Lymphoma
B-cell Lymphoma
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
Cutaneous T-cell Lymphoma
Follicular Lymphoma
Waldenstrom Macroglobulinemia
Lymphoma, Large-cell
Angioimmunoblastic T-cell Lymphoma
Angioimmunoblastic Lymphadenopathy With Dysproteinemia
Hodgkin Lymphoma
Primary Central Nervous System Lymphoma
AL Amyloidosis
Extranodal Nasal NK/T Cell Lymphoma
Aplastic Anemia
Large Granular Lymphocyte Leukemia
Aggressive NK Cell Leukemia
Hodgkin Lymphoma, Childhood
Anaplastic Large Cell Lymphoma
Anaplastic Plasmacytoma
Juvenile Myelomonocytic Leukemia
Lymphoblastic Lymphoma
Sezary Syndrome
Lymphomatoid Granulomatosis
Plasmablastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Hairy Cell Leukemia
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) |
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
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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
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 September 21, 2017