Status:
UNKNOWN
Retrospective Study: Efficacy and Safety of Chlorambucil + Rituximab in CLL Patients
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
CLL
B-cell
Eligibility:
All Genders
18+ years
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 Leuke...
Detailed Description
Illness: treatment overview Chronic lymphocytic leukemia (B-CLL) is the most prevalent adult leukemia among western countries (6.7% Non-Hodgkin Lymphomas- NHL). The incidence rate is 2-6 cases per 100...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01862445
Start Date
October 1 2013
End Date
May 1 2018
Last Update
March 22 2018
Active Locations (20)
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1
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
Ascoli Piceno, Italy
2
UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
Barletta, Italy
3
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
4
Sezione di Ematologia e Fisiopatologia delle Emostasi
Ferrara, Italy