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This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Chronic Lymphocytic Leukemia (CLL) | Patients with diagnosed CLL and eligible to venetoclax as per label |
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| Measure | Description | Time Frame |
|---|---|---|
| Best Response of Venetoclax in Participants with Chronic Lymphocytic Leukemia (CLL) up to 12 Months | The best response is defined as the best response observed during the first year of study treatment among the possible responses to treatment: Complete Response (CR), CR with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR), Partial Response (PR), Stable Disease (SD), or Disease Progression (DP). | Up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time To Next Treatment | The time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation. | Up to approximately 48 months |
| Time to First Response to Treatment (TTR) |
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Inclusion Criteria:
Exclusion Criteria:
- Participating in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation.
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Adult patients starting venetoclax treatment for CLL.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Cannes - les Broussailles /ID# 201108 | Cannes | Alpes-Maritimes | 06414 | France | ||
| CH CARCASSONNE - Antoine Gayraud /ID# 202530 |
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| Label | URL |
|---|---|
| Related Info | View source |
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The time to response to treatment (TTR) is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented the response among CR, CRi, nPR, and PR. |
| Up to approximately 24 months |
| Minimal Residual Disease | The proportion of participants with assessment of the minimal residual disease under venetoclax treatment (assessed by flow cytometry or Polymerase Chain Reaction). | Up to approximately 24 months |
| Overall Response Rate (ORR) | ORR is defined as the proportion of participants who reach either CR, CRi, nPR, or PR to treatment, according to physician's assessment. | Up to approximately 24 months |
| Change in Score of EuroQol 5 Dimensions (EQ-5D-5L) | The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The scores for the 5 dimensions are used to compute a single utility index score ranging from zero (0.0) to 1 (1.0) representing the general health status of the individual. The EQ-5D-5L also contains a visual analog scale (VAS) to assess the subject's overall health. | Up to approximately 24 months |
| Time to Best Response to Treatment | The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the assessment having documented the best response among CR, CRi, nPR, PR, SD, and DP. | Up to approximately 24 months |
| Response Duration | The response duration will be calculated in the sub-population of participants experiencing treatment response (CR, CRi, nPR, or PR) from the date when response is first met to the date of first following documented progression. | Up to approximately 48 months |
| PFS after Disease Progression Following Venetoclax Treatment | The PFS after disease progression following venetoclax treatment will be calculated in the sub-population of patients experiencing disease progression under venetoclax. The PFS following venetoclax treatment is defined as the time from the date of first next CLL treatment intake to the date of the following documented progression or death from any cause. | Up to approximately 48 months |
| Overall survival (OS) | OS is defined as the time from the date of first venetoclax intake to the date of death from any cause. | Up to approximately 48 months |
| Best Response under Next CLL Treatment | The best response under next CLL treatment will be calculated in the sub-population of patients having a next CLL treatment after venetoclax discontinuation. | Up to approximately 48 months |
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression or death from any cause. | Up to approximately 48 months |
| Time To Progression (TTP) | The Time To Progression (TTP) is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression. | Up to approximately 48 months |
| Carcassonne |
| Aude |
| 11000 |
| France |
| CHU Clermont-Ferrand /ID# 170736 | Clermont | Auvergne-Rhône-Alpes | 63100 | France |
| Clinique Pole santé République /ID# 204658 | Clermont-Ferrand | Auvergne | 63050 | France |
| CH de la Haute-Saône - Vesoul /ID# 205150 | Vesoul | Bourgogne-Franche-Comté | 70014 | France |
| CHU de RENNES /ID# 169944 | Rennes | Brittany Region | 35033 | France |
| CHU de Besancon - Jean Minjoz /ID# 170721 | Besançon | Doubs | 25030 | France |
| Centre Hospitalier de Cornouaille /ID# 169937 | Quimper | Finistere | 29000 | France |
| CHU Limoges - Dupuytren 1 /ID# 200193 | Limoges | Franche-Comte | 87042 | France |
| Institut Bergonie /ID# 170746 | Bordeaux | Gironde | 33000 | France |
| CH Roubaix - Hopital Victor Provo /ID# 170909 | Roubaix | Hauts-de-France | 59100 | France |
| CHU Montpellier - Hopital Saint Eloi /ID# 200192 | Montpellier | Herault | 34295 | France |
| CH de Saint-Malo - Hôpital Broussais /ID# 169935 | St-Malo | Ille-et-Vilaine | 35400 | France |
| CHRU Tours - Hopital Bretonneau /ID# 169469 | Tours | Indre-et-Loire | 37044 | France |
| CHU Grenoble - Hopital Michallon /ID# 170741 | La Tronche | Isere | 38700 | France |
| CHU Reims - Hôpital Robert Debre /ID# 170917 | Reims | Marne | 51092 | France |
| CHRU Nancy - Hopitaux de Brabois /ID# 170855 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54500 | France |
| CH Bretagne Atlantique /ID# 200191 | Vannes | Morbihan | 56017 | France |
| CHR Metz-Thionville - Hopital Bel-Air /ID# 170722 | Thionville | Moselle | 57100 | France |
| IUCT Oncopole /ID# 170749 | Toulouse | Occitanie | 31059 | France |
| AP-HP - Hopital Bicetre /ID# 170747 | Le Kremlin-Bicêtre | Paris | 94270 | France |
| Hopital de la Conception /ID# 201981 | Marseille | Provence-Alpes-Côte d'Azur Region | 13005 | France |
| Centre Hospitalier de la Cote Basque /ID# 170735 | Bayonne | Pyrenees-Atlantiques | 64100 | France |
| Centre Leon Berard /ID# 170018 | Lyon | Rhone | 69373 | France |
| Clinique Victor Hugo /ID# 169973 | Le Mans | Sarthe | 72000 | France |
| Centre Hospitalier du Mans /ID# 169451 | Le Mans | Sarthe | 72037 | France |
| Hopital de Melun /ID# 202569 | Melun | Seine-et-Marne | 77011 | France |
| Centre Henri Becquerel /ID# 169948 | Rouen | Seine-Maritime | 76038 | France |
| CHU Amiens-Picardie Site Sud /ID# 170724 | Amiens | Somme | 80054 | France |
| Institut Gustave Roussy /ID# 202436 | Villejuif | Val-de-Marne | 94805 | France |
| CHU Poitiers - La miletrie /ID# 169470 | Poitiers | Vienne | 86000 | France |
| CHI POISSY - Saint-Germain-en-Laye /ID# 169966 | Saint-Germain-en-Laye | Yvelines | 78100 | France |
| Ch Agen /Id# 170742 | Agen | 47923 | France |
| CH Victor Dupouy /ID# 169946 | Argenteuil | 95100 | France |
| Ch Blois /Id# 170727 | Blois | 41016 | France |
| CHRU de Brest - Hopital Morvan /ID# 169457 | Brest | 29200 | France |
| CHU de CAEN - Hopital de la Cote de Nacre /ID# 169941 | Caen | 14033 | France |
| Hopital Prive Sevigne /Id# 170718 | Cesson-Sévigné | 35510 | France |
| Medipole de Savoie /ID# 169454 | Challes-les-Eaux | 73190 | France |
| CH William Morey /ID# 169939 | Chalon-sur-Saône | 71321 | France |
| Centre Hospitalier de CHOLET /ID# 171215 | Cholet | 49300 | France |
| Hopital d'Instruction des Armées PERCY /ID# 170740 | Clamart | 92141 | France |
| Centre Joseph BELOT /ID# 170853 | Désertines | 03030 | France |
| CH Annecy Genevois - Site Annecy /ID# 200826 | Epagny Metz Tessy | 74370 | France |
| Centre Hospitalier de Versailles André Mignot /ID# 169950 | Le Chesnay | 78150 | France |
| CH Libourne - Hopital Robert Boulin /ID# 170739 | Libourne | 33500 | France |
| Hopital Saint Vincent de Paul /ID# 169956 | Lille | 59020 | France |
| Clinique de la Sauvegarde /ID# 169904 | Lyon | 69009 | France |
| CH Princesse Grace /ID# 200196 | Monaco | 98000 | France |
| CH Mont de MARSAN /ID# 169955 | Mont-de-Marsan | 40024 | France |
| Ch Mulhouse /Id# 170726 | Mulhouse | 68100 | France |
| Polyclinique le LANGUEDOC /ID# 169925 | Narbonne | 11100 | France |
| Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 169453 | Orléans | 45067 | France |
| Hôpital Saint-Louis /ID# 170856 | Paris | 75010 | France |
| Centre Hospitalier de Perpignan /ID# 170743 | Perpignan | 66000 | France |
| CH Périgueux /ID# 169458 | Périgueux | 24019 | France |
| CH Saint-Brieuc /ID# 171076 | Saint-Brieuc | 22000 | France |
| Hopital Nord Franche Comté /ID# 170744 | Trévenans | 90400 | France |
| Hopital Avicenne - APHP /ID# 169940 | Bobigny | Île-de-France Region | 93000 | France |
| Hopital Pitie Salpetriere /ID# 169974 | Paris | Île-de-France Region | 75013 | France |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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