An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia
Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera
1 other identifier
observational
327
1 country
84
Brief Summary
This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
Longer than P75 for all trials
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2011
CompletedFirst Submitted
Initial submission to the registry
November 4, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2016
CompletedMarch 22, 2017
March 1, 2017
5.6 years
November 4, 2011
March 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy
2 years
Secondary Outcomes (9)
Overall response rate
2 years
Complete response rate
2 years
Progression-free survival
2 years
Time to next treatment
2 years
Overall survival
2 years
- +4 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Adult patients with relapsing or refractory chronic lymphocytic leukemia (CLL)
You may qualify if:
- Adult patients, \>/=18 years of age
- Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) with first or second relapse
- Previous treatment with MabThera/Rituxan
- MabThera/Rituxan treatment planned for current relapse
You may not qualify if:
- Richter syndrome
- Life expectancy \<6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (84)
Unknown Facility
Aix-en-Provence, 13616, France
Unknown Facility
Aix-en-Provence, 13617, France
Unknown Facility
Albi, 81030, France
Unknown Facility
Angers, 49933, France
Unknown Facility
Antibes, 06600, France
Unknown Facility
Argenteuil, 95107, France
Unknown Facility
Arras, 62022, France
Unknown Facility
Avignon, 84902, France
Unknown Facility
Bayonne, 64109, France
Unknown Facility
Béziers, 34525, France
Unknown Facility
Béziers, 34535, France
Unknown Facility
Blois, 41016, France
Unknown Facility
Bobigny, 93009, France
Unknown Facility
Bordeaux, 33030, France
Unknown Facility
Bordeaux, 33077, France
Unknown Facility
Boulogne, 62321, France
Unknown Facility
Bourg-en-Bresse, 01012, France
Unknown Facility
Brest, 29609, France
Unknown Facility
Caen, 14033, France
Unknown Facility
Caen, 14076, France
Unknown Facility
Carcassonne, 11890, France
Unknown Facility
Castelnau Lez, 34170, France
Unknown Facility
Chalon-sur-Saône, 71321, France
Unknown Facility
Chambéry, 73011, France
Unknown Facility
Clermont-Ferrand, 63003, France
Unknown Facility
Clermont-Ferrand, 63050, France
Unknown Facility
Colmar, 68024, France
Unknown Facility
Compiègne, 60321, France
Unknown Facility
Corbeil-Essonnes, 91000, France
Unknown Facility
Creil, 60109, France
Unknown Facility
Fréjus, 83608, France
Unknown Facility
Grenoble, 38000, France
Unknown Facility
La Source, 45100, France
Unknown Facility
La Tronche, 38700, France
Unknown Facility
Le Mans, 72037, France
Unknown Facility
Libourne, 33505, France
Unknown Facility
Lyon, 69338, France
Unknown Facility
Marseille, 13005, France
Unknown Facility
Marseille, 13291, France
Unknown Facility
Mâcon, 71018, France
Unknown Facility
Melun, 77011, France
Unknown Facility
Metz, 57038, France
Unknown Facility
Metz, 57045, France
Unknown Facility
Metz-Tessy, 74370, France
Unknown Facility
Montauban, 82013, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Mulhouse, 68070, France
Unknown Facility
Nantes, 44093, France
Unknown Facility
Nantes, 44202, France
Unknown Facility
Nice, 06189, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Nîmes, 30029, France
Unknown Facility
Paris, 75181, France
Unknown Facility
Paris, 75475, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Perpignan, 66012, France
Unknown Facility
Perpignan, 66046, France
Unknown Facility
Pessac, 33604, France
Unknown Facility
Pierre-Bénite, 69495, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Pontoise, 95300, France
Unknown Facility
Reims, 51092, France
Unknown Facility
Rennes, 35000, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Roubaix, 59056, France
Unknown Facility
Rouen, 76038, France
Unknown Facility
Saint Prient En Jarez, 42271, France
Unknown Facility
Saint-Brieuc, 22027, France
Unknown Facility
Saint-Germain-en-Laye, 78105, France
Unknown Facility
Saint-Herblain, 44805, France
Unknown Facility
Saint-Quentin, 02321, France
Unknown Facility
Salon-de-Provence, 13658, France
Unknown Facility
Salouël, 80480, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Strasbourg, 67098, France
Unknown Facility
Toulon, 83041, France
Unknown Facility
Toulon, 83056, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Troyes, 10003, France
Unknown Facility
Valence, 26953, France
Unknown Facility
Villejuif, 94804, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2011
First Posted
December 8, 2011
Study Start
April 4, 2011
Primary Completion
October 24, 2016
Study Completion
October 24, 2016
Last Updated
March 22, 2017
Record last verified: 2017-03