An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01488162
Collaborator
(none)
327
84
66.7
3.9
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
327 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera
Actual Study Start Date
:
Apr 4, 2011
Actual Primary Completion Date
:
Oct 24, 2016
Actual Study Completion Date
:
Oct 24, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
- Safety (incidence of adverse events) [2 years]
- Safety (incidence of hematologic adverse events) [2 years]
- Safety (incidence of infections) [2 years]
- Safety (incidence of secondary malignancies) [2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Richter syndrome
-
Life expectancy <6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aix En Provence | France | 13616 | ||
| 2 | Aix En Provence | France | 13617 | ||
| 3 | Albi | France | 81030 | ||
| 4 | Angers | France | 49933 | ||
| 5 | Antibes | France | 06600 | ||
| 6 | Argenteuil | France | 95107 | ||
| 7 | Arras | France | 62022 | ||
| 8 | Avignon | France | 84902 | ||
| 9 | Bayonne | France | 64109 | ||
| 10 | Beziers | France | 34525 | ||
| 11 | Beziers | France | 34535 | ||
| 12 | Blois | France | 41016 | ||
| 13 | Bobigny | France | 93009 | ||
| 14 | Bordeaux | France | 33030 | ||
| 15 | Bordeaux | France | 33077 | ||
| 16 | Boulogne | France | 62321 | ||
| 17 | Bourg En Bresse | France | 01012 | ||
| 18 | Brest | France | 29609 | ||
| 19 | Caen | France | 14033 | ||
| 20 | Caen | France | 14076 | ||
| 21 | Carcassonne | France | 11890 | ||
| 22 | Castelnau Lez | France | 34170 | ||
| 23 | Chalon Sur Saone | France | 71321 | ||
| 24 | Chambery | France | 73011 | ||
| 25 | Clermont Ferrand | France | 63003 | ||
| 26 | Clermont Ferrand | France | 63050 | ||
| 27 | Colmar | France | 68024 | ||
| 28 | Compiegne | France | 60321 | ||
| 29 | Corbeil Essonnes | France | 91000 | ||
| 30 | Creil | France | 60109 | ||
| 31 | Frejus | France | 83608 | ||
| 32 | Grenoble | France | 38000 | ||
| 33 | La Source | France | 45100 | ||
| 34 | La Tronche | France | 38700 | ||
| 35 | Le Mans | France | 72037 | ||
| 36 | Libourne | France | 33505 | ||
| 37 | Lyon | France | 69338 | ||
| 38 | Macon | France | 71018 | ||
| 39 | Marseille | France | 13005 | ||
| 40 | Marseille | France | 13291 | ||
| 41 | Melun | France | 77011 | ||
| 42 | Metz Tessy | France | 74370 | ||
| 43 | Metz | France | 57038 | ||
| 44 | Metz | France | 57045 | ||
| 45 | Montauban | France | 82013 | ||
| 46 | Montpellier | France | 34295 | ||
| 47 | Mulhouse | France | 68070 | ||
| 48 | Nantes | France | 44093 | ||
| 49 | Nantes | France | 44202 | ||
| 50 | Nice | France | 06189 | ||
| 51 | Nice | France | 06202 | ||
| 52 | Nimes | France | 30029 | ||
| 53 | Paris | France | 75181 | ||
| 54 | Paris | France | 75475 | ||
| 55 | Paris | France | 75571 | ||
| 56 | Paris | France | 75651 | ||
| 57 | Paris | France | 75679 | ||
| 58 | Perpignan | France | 66012 | ||
| 59 | Perpignan | France | 66046 | ||
| 60 | Pessac | France | 33604 | ||
| 61 | Pierre Benite | France | 69495 | ||
| 62 | Poitiers | France | 86021 | ||
| 63 | Pontoise | France | 95300 | ||
| 64 | Reims | France | 51092 | ||
| 65 | Rennes | France | 35000 | ||
| 66 | Rennes | France | 35033 | ||
| 67 | Roubaix | France | 59056 | ||
| 68 | Rouen | France | 76038 | ||
| 69 | Saint Herblain | France | 44805 | ||
| 70 | Saint Quentin | France | 02321 | ||
| 71 | Salon De Provence | France | 13658 | ||
| 72 | Salouel | France | 80480 | ||
| 73 | St Brieuc | France | 22027 | ||
| 74 | St Germain En Laye | France | 78105 | ||
| 75 | St Prient En Jarez | France | 42271 | ||
| 76 | Strasbourg | France | 67091 | ||
| 77 | Strasbourg | France | 67098 | ||
| 78 | Toulon | France | 83041 | ||
| 79 | Toulon | France | 83056 | ||
| 80 | Toulouse | France | 31059 | ||
| 81 | Tours | France | 37044 | ||
| 82 | Troyes | France | 10003 | ||
| 83 | Valence | France | 26953 | ||
| 84 | Villejuif | France | 94804 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01488162
Other Study ID Numbers:
- ML25664
First Posted:
Dec 8, 2011
Last Update Posted:
Mar 22, 2017
Last Verified:
Mar 1, 2017