Study to Understand Clinical Characteristics, Treatment Pathway in Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

— CREEK  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964908
• Other study ID #: D8220R00031
• Status: Completed
• Start date: December 3, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1088
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad Autonoma de Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires
Brazil	Research Site	Campinas
Brazil	Research Site	Jau
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Chile	Research Site	Providencia
Colombia	Research Site	Bogota
Colombia	Research Site	Cali
Colombia	Research Site	Medellin
Costa Rica	Research Site	San Jose
Dominican Republic	Research Site	Santo Domingo. D.N.
Egypt	Research Site	Alexandria
Egypt	Research Site	Cairo
Egypt	Research Site	Cairo
Egypt	Research Site	Cairo
Egypt	Research Site	Cairo
Egypt	Research Site	Luxor
India	Research Site	Ahmedabad
India	Research Site	Delhi
India	Research Site	Delhi
India	Research Site	Faridabad
India	Research Site	Haryana
India	Research Site	Hyderabad
India	Research Site	Kashmir
India	Research Site	Kolkata
India	Research Site	Manipal
India	Research Site	Mumbai
Kuwait	Research Site	Kuwait City
Malaysia	Research Site	Johor Bahru
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Selangor
Malaysia	Research Site	Selangor
Mexico	Research Site	Ciudad de Mexico
Mexico	Research Site	Monterrey
Panama	Research Site	Panama City
Saudi Arabia	Research Site	Jeddah
Saudi Arabia	Research Site	Riyadh
Saudi Arabia	Research Site	Riyadh
Singapore	Research Site	Singapore
Singapore	Research Site	Singapore
Singapore	Research Site	Singapore
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei City
Turkey	Research Site	Adana/Saricam
Turkey	Research Site	Ankara/Altindag
Turkey	Research Site	Ankara/Yenimahalle
Turkey	Research Site	Izmir/ Bornova
Turkey	Research Site	Izmir/Balcova
Turkey	Research Site	Samsun/Atakum
United Arab Emirates	Research Site	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Costa Rica,  Dominican Republic,  Egypt,  India,  Kuwait,  Malaysia,  Mexico,  Panama,  Saudi Arabia,  Singapore,  Taiwan,  Turkey,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recording the treatment-related outcomes	Assessment of best response followed the IWCLL 2018 guidelines based on clinical description and biochemistry,	5 years
Primary	To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients	To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic: - Demographics: (Age, gender, race, nationality, Performance status, Tobacco use, Family history of malignancies)	5 year
Primary	Calculation of Epidemiological Measure(s) of Interest	Calculation of Epidemiological Measure(s) of Interest e.g., descriptive statistics, hazard ratios, incidence rates, test/retest reliability)	5 years
Primary	To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients	To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic: Laboratory Status: CBC: Hemoglobin, Total leucocytic count, neutrophils, lymphocytes, and platelets; Renal functions: serum creatinine, Urea, eGFR; Hepatic function: ALT and AST; Concomitant medications: Antagonists of vitamin K; Oral Anticoagulants: rivaroxaban, apixaban, dabigatran; Proton pump inhibitors (PPIs); H2 Antagonists; Antacids; Others	5 Years
Primary	To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients	To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic: Comorbidities.; Risk stratification	5 Years
Primary	To describe disease Characteristics	To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis; Date of diagnosis; Staging of disease	5 Years
Primary	To describe disease Characteristics	To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis; Prognosis made by fluorescence in situ hybridization (FISH); Immunogenetic analysis	5 Years
Secondary	Recording the treatment patterns	Percentage of patients who received immediate therapy and median time of observation, Number of prior lines of treatment received.	5 years
Secondary	Calculation of Epidemiological Measure(s) of Interest	First Treatment received: Number of prior lines of treatment received	5 Years
Secondary	Subsequent lines of therapies	Type of regimen (CIT or targeted therapies) and specific regimens or drugs; Number of cycles; Duration of treatment; Pattern of response at the end of the treatment	5 Years

External Links

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