NCT00993694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

October 9, 2009

Last Update Submit

April 13, 2017

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisorderMethemoglobinemiaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNonmalignant Neoplasm

Keywords

methemoglobinemiaaplastic anemiaaccelerated phase chronic myelogenous leukemiaacute undifferentiated leukemiaatypical chronic myeloid leukemia, BCR-ABL negativeblastic phase chronic myelogenous leukemiachildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiajuvenile myelomonocytic leukemiamast cell leukemiameningeal chronic myelogenous leukemiaprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemiarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiastage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaT-cell large granular lymphocyte leukemiaAIDS-related diffuse large cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related diffuse small cleaved cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related lymphoblastic lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaAIDS-related small noncleaved cell lymphomaHIV-associated Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomastage I childhood Hodgkin lymphomastage II childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomacutaneous B-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromestage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromeWaldenstrom macroglobulinemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II mantle cell lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I mantle cell lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomastage I childhood large cell lymphomastage I childhood lymphoblastic lymphomastage I childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage II childhood lymphoblastic lymphomastage II childhood small noncleaved cell lymphomastage III childhood large cell lymphomastage III childhood lymphoblastic lymphomastage III childhood small noncleaved cell lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV childhood large cell lymphomastage IV childhood lymphoblastic lymphomastage IV childhood small noncleaved cell lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent childhood grade III lymphomatoid granulomatosisrecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaBurkitt lymphomachildhood diffuse large cell lymphomachildhood grade III lymphomatoid granulomatosischildhood immunoblastic large cell lymphomachildhood nasal type extranodal NK/T-cell lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomapost-transplant lymphoproliferative disorderchronic eosinophilic leukemiachronic neutrophilic leukemiaprimary myelofibrosisessential thrombocythemiapolycythemia veraextramedullary plasmacytomaisolated plasmacytoma of bonestage I multiple myelomastage II multiple myelomastage III multiple myelomaprimary systemic amyloidosisrefractory multiple myelomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiablechildhood myelodysplastic syndromesrecurrent childhood anaplastic large cell lymphomastage I childhood anaplastic large cell lymphomastage II childhood anaplastic large cell lymphomastage III childhood anaplastic large cell lymphomastage IV childhood anaplastic large cell lymphomastage III childhood Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

chemotherapyDRUG
dapsoneDRUG
medical chart reviewOTHER
assessment of therapy complicationsPROCEDURE

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisordersMethemoglobinemiaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeoplasmsAnemia, AplasticLeukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcuteLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelomonocytic, JuvenileLeukemia, Mast-CellLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, Large Granular LymphocyticRecurrenceLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeWaldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularLymphoma, Mantle-CellDendritic Cell Sarcoma, InterdigitatingBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Extranodal NK-T-CellIntraocular LymphomaPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicPrimary MyelofibrosisThrombocythemia, EssentialPolycythemia VeraImmunoglobulin Light-chain Amyloidosis

Interventions

Drug TherapyDapsone

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersAnemiaBone Marrow Failure DisordersLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, Myeloid, AcuteMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, B-CellLeukemia, T-CellLymphoma, T-CellLymphoma, Non-HodgkinLymphadenopathyLymphoma, B-CellHistiocytic Disorders, MalignantHistiocytosisEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBone Marrow NeoplasmsHematologic NeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSulfonesSulfur CompoundsOrganic Chemicals

Study Officials

  • Adam J. Esbenshade, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 12, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 17, 2017

Record last verified: 2017-04

Locations

US(2)