Retrospective Study: Efficacy and Safety of Chlorambucil + Rituximab in CLL Patients
A Retrospective Study to Assess the Efficacy and Safety of Chlorambucil Plus Rituximab as Front-line Therapy in Elderly and/or Unfit Patients Affected by B-cell Chronic Lymphocytic Leukemia
1 other identifier
observational
100
1 country
20
Brief Summary
This is a non interventional study to evaluate the efficacy and safety of Chlorambucil plus Rituximab as firstline therapy in elderly and/or unfit patients affected by B-cell Chronic Lymphocytic Leukemia (B-CLL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2013
Longer than P75 for all trials
20 active sites
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
First Submitted
Initial submission to the registry
May 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 24, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 22, 2018
March 1, 2018
4.6 years
May 17, 2013
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of responding patients.
Overall response rate.
10 months from study entry
Secondary Outcomes (4)
Number of adverse events.
24 months from study entry
Number of days from the first dose of treatment to re-treatment.
24 months from study entry.
Number of patients surviving.
24 months from study entry.
Number of patients in which the response and the biological and clinical characteristics of the disease at baseline are associated.
After 10 months from study entry.
Study Arms (1)
Study group
Patients receiving Chlorambucil plus Rituximab
Eligibility Criteria
The GIMEMA Chronic Lymphocytic Leukemia Working Party promotes an observational, retrospective, multicenter study on safety and efficacy of Chl-R administered front-line to treat elderly and/or unfit pts affected by B-CLL.
You may qualify if:
- Have a diagnosis of B-CLL or Small Lymphocytic Lymphoma (SLL) according to the World Health Organisation (WHO) classification 2008;
- Previously untreated B-CLL requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008 (Appendix G) undergone to first line of therapy with Chl-R;
- All patients included in the study must have started treatment by December 2011;
- Age ≥ 65 years or unfit pts ≥ 18 years old with a CIRS score ≥7 (Appendix E);
- Eastern Cooperative Oncology Group Performance Status Grade of 0-2 (Appendix B) ;
- Life expectancy \> 6 months;
- Signed written informed consent according to ICH/EU/GCP and national local law.
You may not qualify if:
- Patients who have received prior therapy: chemotherapy and/or immunotherapy, stem cell transplantation, investigational drugs administered to treat B-CLL before Chl-R;
- Transformation of B-CLL to aggressive lymphomas (Richter's Syndrome);
- One or more individual organ/system impairment score of 4 as assessed by CIRS definition;
- HIV infection;
- Active, uncontrolled HCV and/or HBV infections or liver cirrhosis;
- Patients who started Chl-R after December 2011.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
Ascoli Piceno, Italy
UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
Barletta, Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
Sezione di Ematologia e Fisiopatologia delle Emostasi
Ferrara, Italy
Policlinico di Careggi
Florence, Italy
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
Foggia, Italy
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina, Italy
UO Ematologia - AOU Policlinico di Modena
Modena, Italy
U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani
Nocera Inferiore, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, Italy
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Pesaro, Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
Roma, Italy
U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita
Roma, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
Università degli studi "Sapienza" di Roma
Roma, Italy
A.O. Santa Maria - Terni S.C Oncoematologia
Terni, Italy
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Torino, Italy
Struttura Complessa II Medicina - Ematologia - Centro di Riferimento Ematologico - Ospedale Maggiore
Trieste, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luca Laurenti, Dr.
Istituto di Ematologia, Università Cattolica del Sacro Cuore di Roma
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2013
First Posted
May 24, 2013
Study Start
October 1, 2013
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
March 22, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share