An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01488162
First received: November 4, 2011
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

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
Lymphocytic Leukemia, Chronic

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Complete response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to next treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety (incidence of hematologic adverse events) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety (incidence of infections) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety (incidence of secondary malignancies) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 327
Study Start Date: April 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients with relapsing or refractory chronic lymphocytic leukemia (CLL)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488162

  Hide Study Locations
Locations
France
Aix En Provence, France, 13616
Aix En Provence, France, 13617
Albi, France, 81030
Angers, France, 49933
Antibes, France, 06600
Argenteuil, France, 95107
Arras, France, 62022
Avignon, France, 84902
Bayonne, France, 64109
Beziers, France, 34535
Beziers, France, 34525
Blois, France, 41016
Bobigny, France, 93009
Bordeaux, France, 33077
Bordeaux, France, 33030
Boulogne, France, 62321
Bourg En Bresse, France, 01012
Brest, France, 29609
Caen, France, 14033
Caen, France, 14076
Carcassonne, France, 11890
Castelnau Lez, France, 34170
Chalon Sur Saone, France, 71321
Chambery, France, 73011
Clermont Ferrand, France, 63003
Clermont Ferrand, France, 63050
Colmar, France, 68024
Compiegne, France, 60321
Corbeil Essonnes, France, 91000
Creil, France, 60109
Frejus, France, 83608
Grenoble, France, 38000
La Source, France, 45100
La Tronche, France, 38700
Le Mans, France, 72037
Libourne, France, 33505
Lyon, France, 69338
Macon, France, 71018
Marseille, France, 13291
Marseille, France, 13005
Melun, France, 77011
Metz, France, 57045
Metz, France, 57038
Metz Tessy, France, 74370
Montauban, France, 82013
Montpellier, France, 34295
Mulhouse, France, 68070
Nantes, France, 44093
Nantes, France, 44202
Nice, France, 06202
Nice, France, 06189
Nimes, France, 30029
Paris, France, 75571
Paris, France, 75181
Paris, France, 75651
Paris, France, 75475
Paris, France, 75679
Perpignan, France, 66012
Perpignan, France, 66046
Pessac, France, 33604
Pierre Benite, France, 69495
Poitiers, France, 86021
Pontoise, France, 95300
Reims, France, 51092
Rennes, France, 35033
Rennes, France, 35000
Roubaix, France, 59056
Rouen, France, 76038
Saint Herblain, France, 44805
Saint Quentin, France, 02321
Salon De Provence, France, 13658
Salouel, France, 80480
St Brieuc, France, 22027
St Germain En Laye, France, 78105
St Prient En Jarez, France, 42271
Strasbourg, France, 67091
Strasbourg, France, 67098
Toulon, France, 83041
Toulon, France, 83056
Toulouse, France, 31059
Tours, France, 37044
Troyes, France, 10003
Valence, France, 26953
Villejuif, France, 94804
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01488162     History of Changes
Other Study ID Numbers: ML25664
Study First Received: November 4, 2011
Last Updated: May 11, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 21, 2015