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

March 21, 2017 updated by: Hoffmann-La Roche

Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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, 34525
      • Beziers, France, 34535
      • 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, 14076
      • Caen, France, 14033
      • Carcassonne, France, 11890
      • Castelnau Lez, France, 34170
      • Chalon Sur Saone, France, 71321
      • Chambery, France, 73011
      • Clermont Ferrand, France, 63050
      • Clermont Ferrand, France, 63003
      • 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, 57038
      • Metz, France, 57045
      • 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, 75651
      • Paris, France, 75475
      • Paris, France, 75571
      • Paris, France, 75679
      • Paris, France, 75181
      • Perpignan, France, 66046
      • Perpignan, France, 66012
      • 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, 67098
      • Strasbourg, France, 67091
      • Toulon, France, 83056
      • Toulon, France, 83041
      • Toulouse, France, 31059
      • Tours, France, 37044
      • Troyes, France, 10003
      • Valence, France, 26953
      • Villejuif, France, 94804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years
Progression-free survival
Time Frame: 2 years
2 years
Overall response rate
Time Frame: 2 years
2 years
Time to next treatment
Time Frame: 2 years
2 years
Complete response rate
Time Frame: 2 years
2 years
Safety (incidence of adverse events)
Time Frame: 2 years
2 years
Safety (incidence of hematologic adverse events)
Time Frame: 2 years
2 years
Safety (incidence of infections)
Time Frame: 2 years
2 years
Safety (incidence of secondary malignancies)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2011

Primary Completion (Actual)

October 24, 2016

Study Completion (Actual)

October 24, 2016

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25664

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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