AQUALIS:QoL of CLL Patients Treated With Acalabrutinib in France, Retrospective Study Based on Data From PLATON Database

NCT06548152 | Recruiting

• 1 other identifier: D8220R00057
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

QoL is often not assessed in real-world studies; hence, there is limited understanding about the real-world QoL of patients diagnosed with CLL. Besides, studies evaluating QoL have largely focused on comparing treated and untreated populations. In particular, QoL of patients treated with acalabrutinib has not been evaluated in a real-life setting. The aim of this study is to describe the QoL of CLL patients treated with acalabrutinib between the treatment initiation and twelve months after, in a real-life setting.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia (LLC); Quality of life; Acalabrutinib; France; Retrospective observational study; PLATON database

Outcome Measures

Primary Outcomes (1)

• To measure QoL score of CLL patients treated with acalabrutinib, from treatment initiation and up to 12 months

  * Overall scores and scores in each domain of QoL questionnaires (EORTC-QLQ-C30 ) at acalabrutinib treatment initiation and at 3, 6, 9 and 12 months after initiation * Proportion of patients with an increase, a decrease, or no change in QoL scores over time (between each time point)

  From treatment initiation and up to 12 months

Secondary Outcomes (3)

• To describe QoL and precisely the level of all symptoms

  Treatment initiation

• To describe QoL and precisely the level and evolution of all symptoms

  From treatment initiation and up to 12 months

• Data outcomes analyze and link together

  From treatment initiation and up to 12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be a subgroup of patients enrolled in PLATON database as described below. Inclusion criteria: The following patients will be eligible for inclusion : * Patient enrolled in the PLATON database * Patient ≥18 years old * Treatment naïve CLL patient treated with acalabrutinib in a real life setting. Treatment pattern is Acala mono or Acala + Obinutuzumab * Patient who do not object to his health data collected in PLATON study being re-use for analysis/research purpose * Patients who started Acala but discontinued before 12 months are also included. Exclusion criteria: * Pregnant women * Patients under protection of justice * Patients over the age of 18 and unable to express their non-opposition * Patients with prior CLL treatments

You may qualify if:

• Patient enrolled in the PLATON database
• Patient ≥18 years old
• Treatment naïve CLL patient treated with acalabrutinib in a real life setting. Treatment pattern is Acala mono or Acala + Obinutuzumab
• Patient who do not object to his health data collected in PLATON study being re-use for analysis/research purpose
• Patients who started Acala but discontinued before 12 months are also included.

You may not qualify if:

• Pregnant women
• Patients under protection of justice
• Patients over the age of 18 and unable to express their non-opposition
• Patients with prior CLL treatments

Sponsors & Collaborators

• Hospitalidee: collaborator
• AstraZeneca: lead
• Hospitalidee has been asserted to be a valid organization name by UHToulouse: collaborator

Study Sites (1)

Research Site

Saint-Affrique, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 12, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

FR (1)