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