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

Lymphocytic Leukemia, Chronic Clinical Trial

Official title:

Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395615
• Other study ID #: ML22686
• Status: Completed
• Phase: N/A
• First received: July 14, 2011
• Last updated: November 1, 2016
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life: EuroQol Group EQ-5D questionnaire		18 months	No
Primary	Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire		18 months	No
Primary	Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire		18 months	No