Chronic Lymphocytic LeukemiaCREEKNCT04964908
Study to Understand Clinical Characteristics, Treatment Pathway in Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 52 sites in 17 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 1,088 participants
- Where
- 52 sitesin 17 countries
- Study dates
- 3 Dec 2021to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: with chronic lymphocytic leukemia (CLL) subjects diagnosed
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
52 sites in 17 countries.
52 sites in 17 countries
India10 sites
Research Site
Ahmedabad, 380009
Research Site
Delhi, 110005
Research Site
Delhi, 110017
Research Site
Faridabad, 121001
Research Site
Haryāna, 122002
Research Site
Hyderabad, 500082
Research Site
Kashmīr, 190011
Research Site
Kolkata, 711103
Research Site
Manipal, India, 560017
Research Site
Mumbai, 400012
Egypt6 sites
Research Site
Alexandria, 11591
Research Site
Cairo, 11566
Research Site
Cairo, 11591
Research Site
Cairo, 11796
Research Site
Cairo, 12611
Research Site
Luxor, 85863
Turkey (Türkiye)6 sites
Research Site
Adana/Saricam, Turkey, 1330
Research Site
Ankara/Altindag, 6230
Research Site
Ankara/Yenimahalle, 6560
Research Site
Izmir/ Bornova, Turkey, 35100
Research Site
Izmir/Balcova, Turkey, 35330
Research Site
Samsun/Atakum, Turkey, 55280
Brazil5 sites
Research Site
Campinas, 13083-887
Research Site
Jaú, 17210-080
Research Site
São Paulo, 01236-030
Research Site
São Paulo, 04502-001
Research Site
São Paulo, 1409
Malaysia4 sites
Research Site
Johor Bahru, 80100
Research Site
Kuala Lumpur, 59100
Research Site
Kuala Selangor, Malaysia, 47500
Research Site
Kuala Selangor, Malaysia, 68000
Colombia3 sites
Research Site
Bogotá, 110111
Research Site
Cali, 760045
Research Site
Medellín, 050010
Saudi Arabia3 sites
Research Site
Jeddah, 21423
Research Site
Riyadh, 11426
Research Site
Riyadh, 12231
Singapore3 sites
Research Site
Singapore, 119228
Research Site
Singapore, 168582
Research Site
Singapore, 308433
Argentina2 sites
Research Site
Buenos Aires, C1114
Research Site
Buenos Aires, C1115
Dominican Republic1 site
Research Site
Santo Domingo. D.N., Dominican Republic, 10103
About this study
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.
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
Read the 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
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic lymphocytic leukemia, CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 year
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)
Measured: 5 years
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
Measured: 5 Years
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
Measured: 5 Years
To describe disease Characteristics
To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis
- Date of diagnosis
- Staging of disease
Measured: 5 Years
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
Measured: 5 Years
Secondary outcomes (3)
Recording the treatment patterns
Percentage of patients who received immediate therapy and median time of observation, Number of prior lines of treatment received.
Measured: 5 years
Calculation of Epidemiological Measure(s) of Interest
- First Treatment received:
- Number of prior lines of treatment received
Measured: 5 Years
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
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start3 Dec 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,088 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964908
- Sponsor's protocol ID
- D8220R00031
- Acronym
- CREEK
- Status last verified
- Feb 2024
- First submitted
- 8 Jul 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Abdelmoaty M, Alshehri H, Alamoudi S, Buyukasik Y, Abdelfattah R, Alorabi M, Kamal A, Aboutaleb A, Alhejazi A. Chronic lymphocytic leukaemia in the Middle East: a subgroup analysis from the CREEK study on treatment patterns and outcomes. Expert Rev Anticancer Ther. 2026 Feb;26(2):283-294. doi: 10.1080/14737140.2025.2582649. Epub 2025 Nov 11.
PubMed 41175395
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04964908
- Acronym / sponsor ID
- CREEK / D8220R00031
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic lymphocytic leukemia, CLL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,088 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- with chronic lymphocytic leukemia (CLL) subjects diagnosed
Key inclusion criteria (6 listed)
- 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
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients
Time frame: 5 year
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)
Calculation of Epidemiological Measure(s) of Interest
Time frame: 5 years
Calculation of Epidemiological Measure(s) of Interest e.g., descriptive statistics, hazard ratios, incidence rates, test/retest reliability)
To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients
Time frame: 5 Years
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
To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients
Time frame: 5 Years
To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic: * Comorbidities. * Risk stratification
To describe disease Characteristics
Time frame: 5 Years
To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis * Date of diagnosis * Staging of disease
To describe disease Characteristics
Time frame: 5 Years
To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis * Prognosis made by fluorescence in situ hybridization (FISH) * Immunogenetic analysis
3 secondary outcomes
Recording the treatment patterns
Time frame: 5 years
Calculation of Epidemiological Measure(s) of Interest
Time frame: 5 Years
Subsequent lines of therapies
Time frame: 5 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 41175395Abdelmoaty M, Alshehri H, Alamoudi S, Buyukasik Y, Abdelfattah R, Alorabi M, Kamal A, Aboutaleb A, Alhejazi A. Chronic lymphocytic leukaemia in the Middle East: a subgroup analysis from the CREEK study on treatment patterns and outcomes. Expert Rev Anticancer Ther. 2026 Feb;26(2):283-294. doi: 10.1080/14737140.2025.2582649. Epub 2025 Nov 11.
- CSR Synopsis RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 52 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in India, Egypt, Turkey (Türkiye), Brazil, Malaysia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients (time frame: 5 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04964908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.