An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395615
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will assess the health related quality of life (HQRL) profiles of patients with chronic lymphocytic leukaemia. Using health assessment questionnaires, data will be collected from patients currently receiving therapy and from those who have finished therapy and have undergone an assessment of treatment.

Condition or disease
Lymphocytic Leukemia, Chronic

Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia
Study Start Date : October 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009


Primary Outcome Measures :
  1. Quality of life: EuroQol Group EQ-5D questionnaire [ Time Frame: 18 months ]
  2. Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire [ Time Frame: 18 months ]
  3. Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire [ Time Frame: 18 months ]

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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 chronic lymphocytic leukaemia

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with chronic lymphocytic leukaemia
  • Patients receiving 1st line therapy
  • Patients receiving 2nd line therapy. This will include patients who previously have responded well to 1st line therapy (relapse was >12 months after finishing the 1st line therapy) and are receiving the same therapy again
  • Within the past three months, patients whose treatment has been stopped after 2-3 cycles of 1st or 2nd line therapy and who have not received any further therapies
  • Patients receiving their 3rd, 4th, 5th or 6th cycle of 1st or 2nd line therapy
  • Patients who have completed therapy, are considered stable and are between 3-12 months post therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

  • Clinically significant disorder (other than chronic lymphocytic leukaemia and chronic lymphocytic comorbidities) or any other condition, including alcohol or drug abuse, which may interfere with study participation or affect study conclusions
  • Mental disability or significant mental illness, legal incapacity or limited legal capacity
  • Current high degree of comorbid burden that might affect the accuracy of the quality of life data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01395615

United Kingdom
Bournemouth, United Kingdom, BH7 7DW
Leeds, United Kingdom, LS9 7TF
London, United Kingdom, EC1A 7BE
London, United Kingdom, SE5 9RS
Taunton, United Kingdom, TA1 5DA
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01395615     History of Changes
Other Study ID Numbers: ML22686
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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