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Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia


N/A
18 Years
N/A
Not Enrolling
Both
Lymphocytic Leukemia, Chronic

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Trial Information

Utility Measurement Study for 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Quality of life: EuroQol Group EQ-5D questionnaire

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United Kingdom: Research Ethics Committee

Study ID:

ML22686

NCT ID:

NCT01395615

Start Date:

October 2008

Completion Date:

October 2009

Related Keywords:

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

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