Clinical trial NCT04964908: Study to Understand Clinical Characteristics, Treatment Pathway in Chronic Lymphocytic Leukemia
Official title: CREEK is a Multicenter Retrospective Study to Understand the Clinical Characteristics, Treatment Pathway and Resource Utilization for Patients With Chronic Lymphocytic Leukemia in International Region.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic lymphocytic leukemia
CLL
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 1088
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: with chronic lymphocytic leukemia (CLL) subjects diagnosed

Brief summary: A Multicenter Retrospective Study to understand the clinical characteristics, treatment pathway and resource utilization for patients with chronic lymphocytic leukemia A retrospective, multi-centre, observational study to describe disease characteristics, treatment patterns, treatment-related outcomes, and resource utilization for Chronic Lymphocytic Leukemia (CLL) patients in multiple international regions

Detailed description: CREEK is a retrospective, observational, registry-based study including patients with an incidental diagnosis of CLL and started treatment (1st line, 2nd line, or Subsequent lines of treatment) within the period between 01 June 2016 and 12 months before data collection as identified from the patient records (from participating hospitals across the GCC States and the International region countries) with at least 12 months of follow-up, after starting on treatment.

Moreover, the study will include a pilot cohort in the GCC as an exploratory objective to describe the clinical and patient characteristics for the treatment-naive CLL patient

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Chronic Lymphocytic Leukemia (CLL)
* Initiated CLL treatment (including 1st line, 2nd line, or Subsequent lines of treatment) within the period between 01 June 2016, and 12 months before data collection

  - For GCC pilot cohort patients: treatment-naive CLL patients diagnosed between 01 June 2016, and 12 months before data collection.
* Available medical records at the participating site reflecting at least 12 months of follow-up after starting on treatment (except in the case of the participant death within one year following treatment initiation).
* Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted), according to local regulations.
* Adult male or female ≥18 years old at the time of diagnosis or according to the age of majority as defined by local regulations).

Exclusion Criteria:

* Failure to meet one or more of the inclusion criteria.
* Any diagnosis of B-cell malignancies other than CLL.
* Current or prior use of "acalabrutinib" treatment.
* Currently/previously receiving treatment in an interventional clinical trial at the time of entry into this study for indications CLL.

Primary outcomes:
measure: To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients
timeFrame: 5 year
measure: Calculation of Epidemiological Measure(s) of Interest
timeFrame: 5 years
measure: To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients
timeFrame: 5 Years
measure: To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients
timeFrame: 5 Years
measure: To describe disease Characteristics
timeFrame: 5 Years
measure: To describe disease Characteristics
timeFrame: 5 Years
Secondary outcomes:
measure: Recording the treatment patterns
timeFrame: 5 years
measure: Calculation of Epidemiological Measure(s) of Interest
timeFrame: 5 Years
measure: Subsequent lines of therapies
timeFrame: 5 Years
Other outcomes:
measure: Recording the treatment-related outcomes
timeFrame: 5 years
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
city: Campinas
country: Brazil
facility: Research Site
city: Jau
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Providencia
country: Chile
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Cali
country: Colombia
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
city: San Jose
country: Costa Rica
facility: Research Site
city: Santo Domingo. D.N.
country: Dominican Republic
facility: Research Site
city: Alexandria
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Luxor
country: Egypt
facility: Research Site
city: Ahmedabad
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Faridabad
country: India
facility: Research Site
city: Haryana
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Kashmir
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Manipal
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Kuwait City
country: Kuwait
facility: Research Site
city: Johor Bahru
country: Malaysia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Selangor
country: Malaysia
facility: Research Site
city: Selangor
country: Malaysia
facility: Research Site
city: Ciudad de Mexico
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Panama City
country: Panama
facility: Research Site
city: Jeddah
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Adana/Saricam
country: Turkey
facility: Research Site
city: Ankara/Altindag
country: Turkey
facility: Research Site
city: Ankara/Yenimahalle
country: Turkey
facility: Research Site
city: Izmir/ Bornova
country: Turkey
facility: Research Site
city: Izmir/Balcova
country: Turkey
facility: Research Site
city: Samsun/Atakum
country: Turkey
facility: Research Site
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
Study officials:
References: