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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01488162
First received: November 4, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data wi ll 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 ]

Estimated Enrollment: 320
Study Start Date: April 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 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

Contacts
Contact: Reference Study ID Number: ML25664 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
France
Recruiting
Aix En Provence, France, 13616
Terminated
Aix En Provence, France, 13617
Recruiting
Albi, France, 81030
Recruiting
Angers, France, 49933
Recruiting
Antibes, France, 06600
Recruiting
Argenteuil, France, 95107
Recruiting
Arras, France, 62022
Recruiting
Avignon, France, 84902
Recruiting
Bayonne, France, 64109
Recruiting
Beziers, France, 34535
Recruiting
Beziers, France, 34525
Recruiting
Blois, France, 41016
Recruiting
Bobigny, France, 93009
Recruiting
Bordeaux, France, 33030
Recruiting
Bordeaux, France, 33077
Recruiting
Boulogne, France, 62321
Recruiting
Bourg En Bresse, France, 01012
Recruiting
Brest, France, 29609
Recruiting
Caen, France, 14033
Recruiting
Caen, France, 14076
Recruiting
Carcassonne, France, 11890
Recruiting
Castelnau Lez, France, 34170
Terminated
Chalon Sur Saone, France, 71321
Recruiting
Chalon Sur Saone, France, 71321
Recruiting
Chambery, France, 73011
Recruiting
Clermont Ferrand, France, 63050
Recruiting
Clermont Ferrand, France, 63003
Recruiting
Colmar, France, 68024
Terminated
Compiegne, France, 60321
Recruiting
Corbeil Essonnes, France, 91000
Recruiting
Creil, France, 60109
Recruiting
Frejus, France, 83608
Recruiting
Grenoble, France, 38000
Recruiting
La Source, France, 45100
Recruiting
La Tronche, France, 38700
Recruiting
Le Mans, France, 72037
Recruiting
Libourne, France, 33505
Recruiting
Lyon, France, 69338
Recruiting
Macon, France, 71018
Recruiting
Marseille, France, 13291
Recruiting
Marseille, France, 13005
Terminated
Melun, France, 77011
Recruiting
Metz, France, 57038
Recruiting
Metz, France, 57045
Terminated
Metz Tessy, France, 74370
Recruiting
Metz Tessy, France, 74370
Recruiting
Montauban, France, 82013
Recruiting
Montpellier, France, 34295
Terminated
Montpellier, France, 34295
Recruiting
Mulhouse, France, 68070
Recruiting
Nantes, France, 44093
Recruiting
Nantes, France, 44202
Recruiting
Nice, France, 06202
Recruiting
Nice, France, 06189
Recruiting
Nimes, France, 30029
Recruiting
Paris, France, 75475
Recruiting
Paris, France, 75181
Recruiting
Paris, France, 75651
Recruiting
Paris, France, 75571
Recruiting
Paris, France, 75679
Recruiting
Perpignan, France, 66046
Recruiting
Perpignan, France, 66012
Recruiting
Pessac, France, 33604
Recruiting
Pierre Benite, France, 69495
Recruiting
Poitiers, France, 86021
Recruiting
Pontoise, France, 95300
Recruiting
Reims, France, 51092
Recruiting
Rennes, France, 35000
Recruiting
Rennes, France, 35033
Recruiting
Roubaix, France, 59056
Recruiting
Rouen, France, 76038
Recruiting
Saint Herblain, France, 44805
Recruiting
Saint Quentin, France, 02321
Recruiting
Salon De Provence, France, 13658
Recruiting
Salouel, France, 80480
Recruiting
St Brieuc, France, 22027
Recruiting
St Germain En Laye, France, 78105
Recruiting
St Prient En Jarez, France, 42271
Recruiting
Strasbourg, France, 67091
Terminated
Strasbourg, France, 67091
Recruiting
Strasbourg, France, 67098
Recruiting
Toulon, France, 83041
Recruiting
Toulon, France, 83056
Recruiting
Toulouse, France, 31059
Recruiting
Tours, France, 37044
Recruiting
Troyes, France, 10003
Recruiting
Valence, France, 26953
Recruiting
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: July 7, 2014
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
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014