Chronic Lymphocytic LeukemiaLLC1315NCT02491398
Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 41 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Bendamustine + Rituximab
- How many people
- 494 participants
- Where
- 41 sitesItaly
- Study dates
- Feb 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/) according to the World Health Organisation (WHO) classification 2008.
- 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.
- Previously untreated CLL patients requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of BR as first-line treatment.
- CLL patients 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 (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of bendamustine and rituximab.
- Age ≥ 18 years old.
- Signed written informed consent according to ICH/EU/GCP and national local law.
Who cannot join
- Patients who have received 2 or more lines of prior therapy.
- Patients with:
- Transformation of CLL into aggressive lymphomas (Richter's Syndrome). HIV infection. Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
Italy41 sites
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
Ancona
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
Ascoli Piceno
S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti
Asti
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna
Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio
Bolzano
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Cona
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
Cosenza
S.C. Ematologia ASO S. Croce e Carle
Cuneo
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, 44100
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Florence
UOC di Ematologia con trapianto Ospedale S. Maria Gorett
Latina
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
Meldola
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" P.O. Papardo
Messina
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Milan
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
Milan
Unità Trapianto di Midollo Ist. Nazionale Tumori
Milan
UO Ematologia - AOU Policlinico di Modena
Modena
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padova
U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani
Pagani
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
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
Pavia
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
Piacenza
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
Pisa
Ematologia - Ospedale San Carlo
Potenza
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia
Ospedale "Infermi"
Rimini
U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma
Università degli Studi - Policlinico di Tor Vergata
Roma
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Torino
Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
Udine
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona
ULSS N.6 Osp. S. Bortolo
Vicenza
About this study
Official title: Observational Study to Assess the Efficacy and Safety of Bendamustine Plus Rituximab in Patients Affected by Chronic Lymphocytic Leukemia
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.
Read the detailed description
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.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Bendamustine + Rituximab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendamustine + RituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bendamustine + Rituximab | |
| 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. Receives: Drug: Bendamustine + Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients alive without progression
Progression-free survival
Measured: At 12 months from treatment start
Secondary outcomes (5)
Number of patients untreated
Time-to-next treatment
Measured: At 12 months from treatment start
Number of patients attaining Complete Response (CR)
Measured: At six months, that is, at the end of the induction therapy.
Number of patients attainint CR/partial response (PR)
Measured: At six months, that is, at the end of the induction therapy.
Number of patients alive
Measured: At 12 months from treatment start
Number of patients with grade 3-4 adverse events
Measured: At 12 months from treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Cuneo, Study chair, Ematologia; Azienda Ospedaliera di FerraraGian Matteo Rigolin, Study director, Ematologia; Azienda Ospedaliera di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491398
- Sponsor's protocol ID
- LLC1315
- Acronym
- LLC1315
- Status last verified
- Oct 2020
- First submitted
- 3 Jul 2015
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess the Efficacy and Safety of Bendamustine Plus Rituximab in Patients Affected by Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT02491398
- Acronym / sponsor ID
- LLC1315 / LLC1315
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-line | – | Drug: Bendamustine + RituximabPreviously untreated CLL requiring therapy according to the NCI criteria and treated with at least one cycle of BR as first-line treatment. |
| Second-line | – | Drug: Bendamustine + RituximabCLL 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/) according to the World Health Organisation (WHO) classification 2008.
- 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.
- Previously untreated CLL patients requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of BR as first-line treatment.
- CLL patients 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 (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of bendamustine and rituximab.
- Age ≥ 18 years old.
Key exclusion criteria (3 listed)
- Patients who have received 2 or more lines of prior therapy.
- Patients with:
- Transformation of CLL into aggressive lymphomas (Richter's Syndrome). HIV infection. Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bendamustine + Rituximab | Drug | First-line, Second-line |
Primary outcome
Number of patients alive without progression
Time frame: At 12 months from treatment start
Progression-free survival
5 secondary outcomes
Number of patients untreated
Time frame: At 12 months from treatment start
Number of patients attaining Complete Response (CR)
Time frame: At six months, that is, at the end of the induction therapy.
Number of patients attainint CR/partial response (PR)
Time frame: At six months, that is, at the end of the induction therapy.
Number of patients alive
Time frame: At 12 months from treatment start
Number of patients with grade 3-4 adverse events
Time frame: At 12 months from treatment start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- GIMEMA Foundation websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Cuneo study chair
Ematologia; Azienda Ospedaliera di Ferrara
Gian Matteo Rigolin study director
Ematologia; Azienda Ospedaliera di Ferrara
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 41 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients alive without progression (time frame: At 12 months from treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.