Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With Dapsone
This study has been completed.
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
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
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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:
essential thrombocythemia
head and neck squamous cell carcinoma
methemoglobinemia, beta-globin type
mycosis fungoides
PDGFRA-associated chronic eosinophilic leukemia
Sézary syndrome
MedlinePlus related topics:
Anemia
Aplastic Anemia
Cancer
Leukemia
Multiple Myeloma
Myelodysplastic Syndromes
Drug Information available for:
Dapsone
Genetic and Rare Diseases Information Center resources:
AL Amyloidosis
Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, Childhood
Acute Monoblastic Leukemia
Acute Myeloblastic Leukemia Type 5
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Acute Myeloid Leukemia, Childhood
Acute Non Lymphoblastic Leukemia
Anaplastic Large Cell Lymphoma
Anaplastic Plasmacytoma
Angioimmunoblastic Lymphadenopathy With Dysproteinemia
Angioimmunoblastic T-cell Lymphoma
Aplastic Anemia
B-cell Lymphomas
Burkitt Lymphoma
Central Nervous System Lymphoma, Primary
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Chronic Myeloproliferative Disorders
Chronic Neutrophilic Leukemia
Cutaneous T-cell Lymphoma
Essential Thrombocythemia
Follicular Lymphoma
Hairy Cell Leukemia
Hodgkin Lymphoma
Hodgkin Lymphoma, Childhood
Hypereosinophilic Syndrome
Juvenile Myelomonocytic Leukemia
Large Granular Lymphocyte Leukemia
Leukemia, B-cell, Chronic
Leukemia, Myeloid
Lymphoblastic Lymphoma
Lymphoma, Large-cell
Lymphoma, Large-cell, Immunoblastic
Lymphoma, Small Cleaved-cell, Diffuse
Lymphomatoid Granulomatosis
Lymphosarcoma
Mantle Cell Lymphoma
Multiple Myeloma
Mycosis Fungoides
Myelodysplastic Syndromes
Myelodysplastic/myeloproliferative Disease
Myelofibrosis
Plasmablastic Lymphoma
Polycythemia Vera
Sezary Syndrome
Small Non-cleaved Cell Lymphoma
Squamous Cell Carcinoma of the Head and Neck
Systemic Mastocytosis
Waldenstrom Macroglobulinemia
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) |
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993694
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Principal Investigator: | Adam J. Esbenshade, MD | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| 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:
|
Anemia, Aplastic Lymphoproliferative Disorders Methemoglobinemia Multiple Myeloma Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Preleukemia Anemia Blood Protein Disorders Bone Marrow Diseases |
Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Precancerous Conditions Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015