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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 is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609023
First received: May 29, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
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:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Complete response rate (CR) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Patients with CD20-positive B-cell chronic lymphocytic leukaemia eligible for 1st line or 2nd line therapy

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609023

Contacts
Contact: Please reference Study ID Number: ML22235 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Greece
Recruiting
Alexandroupolis, Greece, 68100
Recruiting
Athens, Greece, 11527
Recruiting
Athens, Greece, 10676
Not yet recruiting
Heraklion, Greece, 71110
Recruiting
Larissa, Greece, 41110
Recruiting
Patra, Greece, 26335
Recruiting
Patras, Greece, 26500
Recruiting
Thessaloniki, Greece, 57010
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: NCT01609023     History of Changes
Other Study ID Numbers: ML22235
Study First Received: May 29, 2012
Last Updated: May 7, 2013
Health Authority: Greece: Ministry of Health and Welfare

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 May 22, 2013