An Observational Study of First-Line Maintenance Rituximab (MabThera/Rituxan) in Participants With Follicular Non-Hodgkin's Lymphoma
28 december 2017 bijgewerkt door: Hoffmann-La Roche
Prospective, Non Interventional Study to Evaluate the Safety Profile of First- Line Rituximab Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma
This prospective observational study will evaluate the safety and efficacy of first-line rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma.
Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of 3 years or until disease progression occurs.
Studie Overzicht
Studietype
Observationeel
Inschrijving (Werkelijk)
22
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Skopje, Macedonië, de Voormalige Joegoslavische Republiek, 1000
- University Clinic of Hematology Skopje, Hospital Care Department
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Participants with follicular non-Hodgkin's lymphoma receiving first-line rituximab maintenance treatment
Beschrijving
Inclusion Criteria:
- Histological diagnosis of follicular non-Hodgkin's lymphoma
- Complete or partial response to first-line induction therapy with chemotherapy with rituximab
- Participants about to receive first-line rituximab maintenance treatment for follicular non-Hodgkin's lymphoma according to the local label
Exclusion Criteria:
- Pregnant or lactating women
- Receipt of an investigational drug within 30 days prior to initiation of observational drug
- Any medical or psychological alteration that, to criterion of the investigator, can jeopardize the capacity of the participant to grant informed consent
- Central nervous system involvement
- Hepatitis B or C virus infection or human immunodeficiency virus infection
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Non-Hodgkin's Lymphoma Participants
Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will receive rituximab for maximum two years or until disease progression.
Participants will be followed for one year after last dose of rituximab administered as maintenance.
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Due to observational nature of the study protocol does not specify any dosing schedule for rituximab.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Percentage deelnemers met bijwerkingen
Tijdsspanne: Baseline tot ongeveer 3 jaar
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Baseline tot ongeveer 3 jaar
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Progression-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
Tijdsspanne: Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
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Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
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Time to Progression, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
Tijdsspanne: Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
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Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
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Time to Next Anti-Lymphoma Treatment (TTNLT)
Tijdsspanne: Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (up to approximately 3 years)
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Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (up to approximately 3 years)
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Time to Next Chemotherapy Treatment (TTNCT)
Tijdsspanne: Baseline up to institution of a chemotherapy regimen or cytotoxic agent or radio-immunotherapy (up to approximately 3 years)
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Baseline up to institution of a chemotherapy regimen or cytotoxic agent or radio-immunotherapy (up to approximately 3 years)
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Overall Survival
Tijdsspanne: Baseline up to death (up to approximately 3 years)
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Baseline up to death (up to approximately 3 years)
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Event-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
Tijdsspanne: Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
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Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
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Percentage of Participants with Overall Response of Complete (CR/CRu) or Partial Response, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
Tijdsspanne: Baseline up to disease progression or death (assessed at baseline and every 8 weeks thereafter until disease progression or death [till the end of rituximab maintenance therapy, up to 2 years])
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Baseline up to disease progression or death (assessed at baseline and every 8 weeks thereafter until disease progression or death [till the end of rituximab maintenance therapy, up to 2 years])
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 oktober 2012
Primaire voltooiing (Werkelijk)
27 november 2017
Studie voltooiing (Werkelijk)
27 november 2017
Studieregistratiedata
Eerst ingediend
11 september 2012
Eerst ingediend dat voldeed aan de QC-criteria
11 september 2012
Eerst geplaatst (Schatting)
13 september 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 december 2017
Laatste update ingediend die voldeed aan QC-criteria
28 december 2017
Laatst geverifieerd
1 december 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Lymfoom
- Lymfoom, folliculair
- Lymfoom, non-Hodgkin
- Fysiologische effecten van medicijnen
- Antireumatische middelen
- Antineoplastische middelen
- Immunologische factoren
- Antineoplastische middelen, immunologisch
- Rituximab
Andere studie-ID-nummers
- ML27993
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