PERLE - Prospective pharmaco-epidemiological study aiming to describe the management of relapsed or refractory chronic lymphocytic leukemia (CLL) patients retreated with MabThera®

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Roche Medical data center

Last update : 11/08/2021 | Version : 1 | ID : 74091

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Prospective pharmaco-epidemiological study aiming to describe the management of relapsed or refractory chronic lymphocytic leukemia (CLL) patients retreated with MabThera®
Sign or acronym PERLE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ML25664
General Aspects
Medical area Hematology
Study in connection with Covid-19 No
Pathology (details) Chronic Lymphocytic Leukemia
Health determinants Medicine
Keywords rituximab
Scientific investigator(s) (Contact)
Name of the director Roche Medical data center
Address 4 cours de l'Ile Seguin - 92100 Boulogne-Billancourt
Email data_sharing.france@roche.com
Organization Roche SAS
Collaborations
Participation in projects, networks and consortia No
Funding
Funding status Private
Governance of the database
Sponsor(s) or organisation(s) responsible Roche SAS
Organisation status Private
Presence of scientific or steering committees Yes
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
Database recruitment is carried out by an intermediary A selection of health care professionals
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Database objective
Main objective Primary Objective: To describe the chemotherapy regimens combined with MabThera® in relapsed or refractory CLL patients having previously received a first or second-line
treatment containing MabThera®
Secondary Objectives:
- Describe efficacy of treatment: overall response (OR), complete response (CR), partial response (PR), progression-free survival (PFS), time to next treatment (TTNT), overall survival (OS) in the total cohort and in the following subgroups: refractory (Yes/No), age (< or >= 70 years), 17p deletion (Yes/No), 11q deletion (Yes/No).
- Describe the choice of chemotherapy regimen in patient subgroups defined as: refractory (Yes/No), age (< or >= 70 years), 17p deletion (Yes/No), 11q deletion (Yes/No)
- Describe MabThera® treatment regimens (dose, number of cycles),
- Describe safety of treatment: all adverse events occurring during the study,
- Describe hospitalizations related to an adverse event throughout the study period.
Exploratory Objectives:
-Analysis of maximal response duration at last line before inclusion will be performed quantitatively and by classes, overall and by age, in all patients and according to number of previous lines of treatment.
- Primary criterion will be also described according to the following subgroups:
- last previous treatment before current relapse included the same/not the same chemotherapy treatment as first induction treatment
- report of Normalized creatinine clearance result < 60 (ml/min/1.73 m²) at baseline (yes/no) (renal insufficiency).
- In patients with HBs antigen positive or anti-HBc antibody positive, analysis of HBV prophylaxis and HBV treatment will be performed by visit
- Multinomial regression on choice of chemotherapy given at first cycle
- Logistic model on response
Inclusion criteria Inclusion criteria:
- Adult patient (age >= 18 years)
- Presenting with chronic lymphocytic leukemia confirmed by immunophenotyping of circulating lymphocytes (Matutes score >= 4)
- In relapse or refractory after a first or second line of treatment
- Receiving at least one line of treatment containing MabThera®
- MabThera® treatment planned for current relapse
- Having received oral and written information about the study and having raised no objections to computer processing of his/her personal data.
Exclusion criteria:
- Patient with Richter syndrome
- Patient with life expectancy < 6 months
- Patient who received 3 or more previous treatment lines*
- Patient previously enrolled in this study
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Pathology C81-C96 - Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
Gender Male
Woman
Geography area National
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2011
Date of last collection (YYYY or MM/YYYY) 2016
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 327
Data
Database activity Data collection completed
Type of data collected Clinical data
Clinical data (detail) Medical registration
Details of collected clinical data Type of data collected : previous medical history and concomitant disorders, cycles of therapy administered, laboratory test data, efficacy, evaluation of patient, adverse events, early permanent discontinuation, history of CLL, verification of screening criteria before inclusion, treatment programme initially planned for treatment of this relapse (or of this refractory condition) of CLL, current relapse (or refractory condition) of CLL, previous treatments of CLL, demographic data, prophylaxis or anti-infective treatment, hematopoietic stem cell transplantations, Richter’s syndrome.
Presence of a biobank No
Procedures
Data collection method eCRF
Classifications used CDISC like
Quality procedure(s) used GCP/GVP
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the referring doctor
Followed pathology C81-C96 - Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
Links to administrative sources No
Promotion and access
Promotion
Access
Dedicated website https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html
Presence of document that lists variables and coding procedures Yes
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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