NCT04964908

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,088

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
16 countries

49 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 3, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

July 8, 2021

Last Update Submit

February 16, 2024

Conditions

Keywords

Chronic lymphocytic leukemiaCLL

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • To describe disease Characteristics

    To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis * Date of diagnosis * Staging of disease

    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

    5 Years

Secondary Outcomes (3)

  • Recording the treatment patterns

    5 years

  • Calculation of Epidemiological Measure(s) of Interest

    5 Years

  • Subsequent lines of therapies

    5 Years

Other Outcomes (1)

  • Recording the treatment-related outcomes

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

with chronic lymphocytic leukemia (CLL) subjects diagnosed

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (52)

Research Site

Buenos Aires, C1114, Argentina

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Research Site

Buenos Aires, C1115, Argentina

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Research Site

Campinas, 13083-887, Brazil

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Jaú, 17210-080, Brazil

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São Paulo, 01236-030, Brazil

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São Paulo, 04502-001, Brazil

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Research Site

São Paulo, 1409, Brazil

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Providencia, 7500000, Chile

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Research Site

Bogotá, 110111, Colombia

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Cali, 760045, Colombia

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Medellín, 050010, Colombia

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San José, 10203, Costa Rica

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Santo Domingo. D.N., Dominican Republic, 10103, Dominican Republic

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Alexandria, 11591, Egypt

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Research Site

Cairo, 11566, Egypt

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Cairo, 11591, Egypt

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Cairo, 11796, Egypt

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Cairo, 12611, Egypt

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Luxor, 85863, Egypt

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Manipal, India, 560017, India

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Ahmedabad, 380009, India

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Research Site

Delhi, 110005, India

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Research Site

Delhi, 110017, India

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Faridabad, 121001, India

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Haryāna, 122002, India

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Hyderabad, 500082, India

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Kashmīr, 190011, India

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Kolkata, 711103, India

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Mumbai, 400012, India

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Kuwait City, 42262, Kuwait

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Kuala Selangor, Malaysia, 47500, Malaysia

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Research Site

Kuala Selangor, Malaysia, 68000, Malaysia

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Johor Bahru, 80100, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Mexico City, 06726, Mexico

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Monterrey, 64460, Mexico

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Panama City, Panama 4, Panama

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Jeddah, 21423, Saudi Arabia

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Riyadh, 11426, Saudi Arabia

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Riyadh, 12231, Saudi Arabia

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Singapore, 119228, Singapore

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Singapore, 168582, Singapore

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Singapore, 308433, Singapore

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Taichung, 407219, Taiwan

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Taipei, 100225, Taiwan

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Research Site

Adana/Saricam, Turkey, 1330, Turkey (Türkiye)

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Research Site

Izmir/ Bornova, Turkey, 35100, Turkey (Türkiye)

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Research Site

Izmir/Balcova, Turkey, 35330, Turkey (Türkiye)

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Research Site

Samsun/Atakum, Turkey, 55280, Turkey (Türkiye)

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Research Site

Ankara/Altindag, 6230, Turkey (Türkiye)

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Research Site

Ankara/Yenimahalle, 6560, Turkey (Türkiye)

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Research Site

Abu Dhabi, 11001, United Arab Emirates

Location

Related Publications (1)

  • 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. 2025 Nov 11:1-12. doi: 10.1080/14737140.2025.2582649. Online ahead of print.

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 16, 2021

Study Start

December 3, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

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.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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 deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Url Preview for AstraZeneca Clinical Trials Website AstraZeneca Clinical Trials Website This web site provides clinical trial data, results and other information regarding clinical trials astrazenecagrouptrials.pharmacm.com
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