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This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a first or second treatment with drugs named bendamustine and rituximab. It will observe the results of this treatment and evaluate its efficacy and side effects.
This cohort study will recruit chronic lymphocytic leukemia (CLL) patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group, and aims at observing the progression-free survival in CLL patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First-line | Previously untreated CLL requiring therapy according to the NCI criteria and treated with at least one cycle of BR as first-line treatment. |
| |
| Second-line | CLL that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the NCI criteria and treated with at least one cycle of BR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine + Rituximab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients alive without progression | Progression-free survival | At 12 months from treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients untreated | Time-to-next treatment | At 12 months from treatment start |
| Number of patients attaining Complete Response (CR) | At six months, that is, at the end of the induction therapy. |
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Inclusion Criteria:
Exclusion Criteria:
Transformation of CLL into aggressive lymphomas (Richter's Syndrome). HIV infection. Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.
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This cohort study will recruit chronic lymphocytic leukemia (CLL) patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Cuneo | Ematologia; Azienda Ospedaliera di Ferrara | Study Chair |
| Gian Matteo Rigolin | Ematologia; Azienda Ospedaliera di Ferrara | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI | Ancona | Italy | ||||
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| Label | URL |
|---|---|
| GIMEMA Foundation website | View source |
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| Number of patients attainint CR/partial response (PR) | At six months, that is, at the end of the induction therapy. |
| Number of patients alive | At 12 months from treatment start |
| Number of patients with grade 3-4 adverse events | At 12 months from treatment start |
| U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno |
| Ascoli Piceno |
| Italy |
| S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti | Asti | Italy |
| Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi | Bologna | Italy |
| Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio | Bolzano | Italy |
| ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO | Cagliari | Italy |
| Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" | Catania | Italy |
| Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia | Catanzaro | Italy |
| Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi | Cona | Italy |
| U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza | Cosenza | Italy |
| S.C. Ematologia ASO S. Croce e Carle | Cuneo | Italy |
| Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna | Ferrara | 44100 | Italy |
| Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano | Florence | Italy |
| UOC di Ematologia con trapianto Ospedale S. Maria Gorett | Latina | Italy |
| Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST | Meldola | Italy |
| Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" P.O. Papardo | Messina | Italy |
| Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano | Milan | Italy |
| U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele | Milan | Italy |
| Unità Trapianto di Midollo Ist. Nazionale Tumori | Milan | Italy |
| UO Ematologia - AOU Policlinico di Modena | Modena | Italy |
| S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro | Novara | Italy |
| Università degli Studi di Padova - Ematologia ed Immunologia Clinica | Padova | Italy |
| U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani | Pagani | Italy |
| U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone" | Palermo | Italy |
| Cattedra di Ematologia CTMO Università degli Studi di Parma | Parma | Italy |
| S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo | Pavia | Italy |
| Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto | Piacenza | Italy |
| Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia | Pisa | Italy |
| Ematologia - Ospedale San Carlo | Potenza | Italy |
| Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" | Reggio Calabria | Italy |
| Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova | Reggio Emilia | Italy |
| Ospedale "Infermi" | Rimini | Italy |
| U.O. di Ematologia - Centro Oncologico Basilicata | Rionero in Vulture | Italy |
| Università Cattolica del Sacro Cuore - Policlinico A. Gemelli | Roma | Italy |
| Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia | Roma | Italy |
| Università degli Studi - Policlinico di Tor Vergata | Roma | Italy |
| U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte" | Siena | Italy |
| Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino" | Torino | Italy |
| Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine | Udine | Italy |
| Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi | Verona | Italy |
| ULSS N.6 Osp. S. Bortolo | Vicenza | Italy |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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