Efficacy and Safety Study of Bendamustine With or Without Rituximab in Chronic Lymphoproliferative Disorders
12. april 2013 opdateret af: Gruppo Italiano Studio Linfomi
A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, As Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders
The purpose of this study is collect and evaluate the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
All patients who meet the criteria for inclusion will be included in the study.
A specific database will be created to collect the following information: personal data, medical history, histology related to the underlying disease, comorbidities, laboratory data, initial staging, data on the dosage and the number of cycles administered, the recorded toxicity data, the clinical response and the main events (relapse, progression, death, and cause of death).
These data will then be retrospectively examined in order to obtain information about the life-saving treatment.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
109
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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CZ
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Cosenza, CZ, Italien, 87100
- UO di Ematologia, S.O. Annunziata
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MO
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Modena, MO, Italien, 41124
- Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Universita' di Modena e Reggio Emilia
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PA
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Palermo, PA, Italien, 90127
- UO di Ematologia, AOUP Paolo Giaccone,
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
All patients with relapsed or refractory chronic lymphoproliferative disorders treated with Bendamustine +/- Rituximab
Beskrivelse
Inclusion Criteria:
- patients with relapsed or refractory chronic lymphoproliferative disorders
- salvage treatment with Bendamustine +/- Rituximab
- age ≥ 18 years
Exclusion Criteria:
- previous treatment with Bendamustine
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Response Rate (ORR)
Tidsramme: At least 2 months after completion of therapy
|
Evaluate the activity of Bendamustine +/- Rituximab in term of ORR
|
At least 2 months after completion of therapy
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival (PFS) and Overall Survival (OS)
Tidsramme: From the date of frist treatment cycle until the date of first documented progression or date of death for any cause, whichever came first, assessed up to 150 months
|
Evaluate the activity of Bendamustine +/- Rituximab in term of PFS and OS
|
From the date of frist treatment cycle until the date of first documented progression or date of death for any cause, whichever came first, assessed up to 150 months
|
|
Number of Adverse Events
Tidsramme: From the date of first tratment cycle until 6 months after the date of last treatment cycle
|
Assess to efficacy of Bendamustine +/- Rituximab in term of grade III and IV National Cancer Institute Common Toxicity Criteria (NCI CTC) adverse events
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From the date of first tratment cycle until 6 months after the date of last treatment cycle
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Stefano Luminari, MD, Gruppi Italiano Studi Linfomi
- Ledende efterforsker: Emilio Iannitto, MD, Gruppo Italiano Studio Linfomi
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Hallek M, Schmitt B, Wilhelm M, Busch R, Krober A, Fostitsch HP, Sezer O, Herold M, Knauf W, Wendtner CM, Kuse R, Freund M, Franke A, Schriever F, Nerl C, Dohner H, Thiel E, Hiddemann W, Brittinger G, Emmerich B; German Chronic Lymphocytic Leukaemia Study Group. Fludarabine plus cyclophosphamide is an efficient treatment for advanced chronic lymphocytic leukaemia (CLL): results of a phase II study of the German CLL Study Group. Br J Haematol. 2001 Aug;114(2):342-8. doi: 10.1046/j.1365-2141.2001.02959.x.
- Wierda W, O'Brien S, Wen S, Faderl S, Garcia-Manero G, Thomas D, Do KA, Cortes J, Koller C, Beran M, Ferrajoli A, Giles F, Lerner S, Albitar M, Kantarjian H, Keating M. Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for relapsed and refractory chronic lymphocytic leukemia. J Clin Oncol. 2005 Jun 20;23(18):4070-8. doi: 10.1200/JCO.2005.12.516. Epub 2005 Mar 14.
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- Bergmann MA, Goebeler ME, Herold M, Emmerich B, Wilhelm M, Ruelfs C, Boening L, Hallek MJ; German CLL Study Group. Efficacy of bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase I/II study of the German CLL Study Group. Haematologica. 2005 Oct;90(10):1357-64.
- Cheson BD, Wendtner CM, Pieper A, Dreyling M, Friedberg J, Hoelzer D, Moreau P, Gribben J, Knop S, Montillo M, Rummel M. Optimal use of bendamustine in chronic lymphocytic leukemia, non-Hodgkin lymphomas, and multiple myeloma: treatment recommendations from an international consensus panel. Clin Lymphoma Myeloma Leuk. 2010 Feb;10(1):21-7. doi: 10.3816/CLML.2010.n.002.
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- Giannopoulos K, Dmoszynska A, Kowal M, Wasik-Szczepanek E, Bojarska-Junak A, Rolinski J, Dohner H, Stilgenbauer S, Bullinger L. Thalidomide exerts distinct molecular antileukemic effects and combined thalidomide/fludarabine therapy is clinically effective in high-risk chronic lymphocytic leukemia. Leukemia. 2009 Oct;23(10):1771-8. doi: 10.1038/leu.2009.98. Epub 2009 May 14.
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- Lissitchkov T, Arnaudov G, Peytchev D, Merkle Kh. Phase-I/II study to evaluate dose limiting toxicity, maximum tolerated dose, and tolerability of bendamustine HCl in pre-treated patients with B-chronic lymphocytic leukaemia (Binet stages B and C) requiring therapy. J Cancer Res Clin Oncol. 2006 Feb;132(2):99-104. doi: 10.1007/s00432-005-0050-z. Epub 2005 Nov 15.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2010
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. januar 2011
Datoer for studieregistrering
Først indsendt
8. april 2013
Først indsendt, der opfyldte QC-kriterier
12. april 2013
Først opslået (Skøn)
16. april 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. april 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. april 2013
Sidst verificeret
1. april 2013
Mere information
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Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RetroBENDA
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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