Status:

RECRUITING

A Study to Assess Change in Functioning and Health Related Quality of Life in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Treatments in Routine Clinical Practice in Spain

Lead Sponsor:

AbbVie

Conditions:

Chronic Lymphocytic Leukemia

Eligibility:

All Genders

18+ years

Brief Summary

Chronic lymphocytic leukemia (CLL) is the most common leukemia in the Western world. Since in most cases CLL remains an incurable disease, the goals of therapy are to improve quality of life and to pr...

Eligibility Criteria

Inclusion

  • Have documented chronic lymphocytic leukemia (CLL) according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
  • Under oral treatment for CLL, either first-line or relapsed/refractory (R/R) therapy.
  • Treatment for CLL started 9 months (+/- 4 weeks) before inclusion for first-line therapy or 21 months (+/- 4 weeks) before inclusion for R/R, under authorized conditions.
  • In the opinion of the investigator, cognitive ability to understand and answer the questionnaires specified in the study protocol.
  • Able to comply with the study protocol in the investigator's judgment.

Exclusion

  • Currently receiving any chemotherapy or chemoimmunotherapy.
  • Transformation of CLL to aggressive non-Hodgkin's lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukaemia).
  • Currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.

Key Trial Info

Start Date :

November 6 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 1 2026

Estimated Enrollment :

132 Patients enrolled

Trial Details

Trial ID

NCT06125795

Start Date

November 6 2023

End Date

July 1 2026

Last Update

September 29 2025

Active Locations (25)

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Page 1 of 7 (25 locations)

1

HUA - Txagorritxu /ID# 258263

Vitoria-Gasteiz, Alava, Spain, 01009

2

Sant Joan de Deu de Manresa /ID# 258266

Manresa, Barcelona, Spain, 08423

3

Hospital Universitari Mútua Terrassa /ID# 258267

Terrassa, Barcelona, Spain, 08221

4

Hospital Jerez De La Frontera /ID# 258282

Jerez de la Frontera, Cadiz, Spain, 11407