FRESH-PEF74091-en
Prospective pharmaco-epidemiological study aiming to describe the management of relapsed or refractory chronic lymphocytic leukemia (CLL) patients retreated with MabThera®
PERLE
| Name | Country code |
|---|---|
| France | fr |
['Clinical data']
Individuals
| Topic | Vocabulary |
|---|---|
| Hematology | health theme |
| Neoplasms of haematopoietic or lymphoid tissues | cim-11 |
| Healthcare system determinants: Use of care | health determinant |
| Healthcare system determinants | health determinant |
{"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"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. ","clusion_E":"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"}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
| Agency name |
|---|
| Other |
['Through independent healthcare practitioners']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2011-01-01 | 2016-01-01 |
| Standard |
|---|
| ['CDISC like'] |
['GCP/GVP']
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
| Name | |
|---|---|
| ;Medical data center | data_sharing.france@roche.com |