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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609023
First received: May 29, 2012
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This observational study will evaluate the safety and efficacy of MabThera/Ritux an (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 Sum mary 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:


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 ]

Enrollment: 70
Study Start Date: April 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 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
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: NCT01609023

Locations
Greece
Alexandroupolis, Greece, 68100
Athens, Greece, 18547
Athens, Greece, 106 76
Athens, Greece, 115 27
Heraklion, Greece, 711 10
Larissa, Greece, 41110
Patra, Greece, 26335
Patras, Greece, 265 00
Thessaloniki, Greece, 570 10
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: September 22, 2014
Health Authority: Greece: Ministry of Health and Welfare

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

ClinicalTrials.gov processed this record on October 01, 2014