Clinical trial NCT01488162: An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia
Official title: Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with relapsing or refractory chronic lymphocytic leukemia (CLL)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy
timeFrame: 2 years
Secondary outcomes:
measure: Overall response rate
timeFrame: 2 years
measure: Complete response rate
timeFrame: 2 years
measure: Progression-free survival
timeFrame: 2 years
measure: Time to next treatment
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Safety (incidence of adverse events)
timeFrame: 2 years
measure: Safety (incidence of hematologic adverse events)
timeFrame: 2 years
measure: Safety (incidence of infections)
timeFrame: 2 years
measure: Safety (incidence of secondary malignancies)
timeFrame: 2 years
Other outcomes:
Locations:
city: Aix En Provence
country: France
city: Aix En Provence
country: France
city: Albi
country: France
city: Angers
country: France
city: Antibes
country: France
city: Argenteuil
country: France
city: Arras
country: France
city: Avignon
country: France
city: Bayonne
country: France
city: Beziers
country: France
city: Beziers
country: France
city: Blois
country: France
city: Bobigny
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Boulogne
country: France
city: Bourg En Bresse
country: France
city: Brest
country: France
city: Caen
country: France
city: Caen
country: France
city: Carcassonne
country: France
city: Castelnau Lez
country: France
city: Chalon Sur Saone
country: France
city: Chambery
country: France
city: Clermont Ferrand
country: France
city: Clermont Ferrand
country: France
city: Colmar
country: France
city: Compiegne
country: France
city: Corbeil Essonnes
country: France
city: Creil
country: France
city: Frejus
country: France
city: Grenoble
country: France
city: La Source
country: France
city: La Tronche
country: France
city: Le Mans
country: France
city: Libourne
country: France
city: Lyon
country: France
city: Macon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Melun
country: France
city: Metz Tessy
country: France
city: Metz
country: France
city: Metz
country: France
city: Montauban
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Nantes
country: France
city: Nantes
country: France
city: Nice
country: France
city: Nice
country: France
city: Nimes
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Perpignan
country: France
city: Pessac
country: France
city: Pierre Benite
country: France
city: Poitiers
country: France
city: Pontoise
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rennes
country: France
city: Roubaix
country: France
city: Rouen
country: France
city: Saint Herblain
country: France
city: Saint Quentin
country: France
city: Salon De Provence
country: France
city: Salouel
country: France
city: St Brieuc
country: France
city: St Germain En Laye
country: France
city: St Prient En Jarez
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Toulon
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Troyes
country: France
city: Valence
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: