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An Observational Study of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With CD20-Positive B-Cell Chronic Lymphocytic Leukaemia

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 29, 2012
Last updated: November 1, 2016
Last verified: November 2016
This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) in combination with chemotherapy in 1st and 2nd line treatment of patients with CD20-positive C-cell chronic lymphocytic leukaemia. Data will be collected from eligible patients receiving MabThera/Rituxan according to the Summary of Product Characteristics during 6 months of treatment.

Lymphocytic Leukemia, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Phase IV Non Interventional Study Evaluating Further the Safety of Rituximab in Combination With Various Chemotherapies for the Treatment of Patients With CD20- Positive B-cell Chronic Lymphocytic Leukaemia in Greece

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 2.5 years ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: 2.5 years ]
  • Complete response rate (CR) [ Time Frame: 2.5 years ]

Enrollment: 67
Study Start Date: April 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with CD20-positive B-cell chronic lymphocytic leukaemia eligible for 1st line or 2nd line therapy

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with CD20-positive B-cell chronic lymphocytic leukaemia eligible for 1st line or 2nd line therapy according to the approved summary of product characteristics (SPC)

Exclusion Criteria:

  • Contraindications to MabThera/Rituxan therapy according to the approved SPC
  Contacts and Locations
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Please refer to this study by its identifier: NCT01609023

Alexandroupolis, Greece, 68100
Athens, Greece, 106 76
Athens, Greece, 115 27
Athens, Greece, 18547
Heraklion, Greece, 711 10
Larissa, Greece, 41110
Patras, Greece, 265 00
Patra, Greece, 26335
Thessaloniki, Greece, 570 10
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01609023     History of Changes
Other Study ID Numbers: ML22235
Study First Received: May 29, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on April 26, 2017