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

February 16, 2024 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1088

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1114
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Argentina, C1115
        • Research Site
  • Brazil
      • Campinas, Brazil, 13083-887
        • Research Site
      • Jau, Brazil, 17210-080
        • Research Site
      • Sao Paulo, Brazil, 01236-030
        • Research Site
      • Sao Paulo, Brazil, 04502-001
        • Research Site
      • Sao Paulo, Brazil, 1409
        • Research Site
  • Chile
      • Providencia, Chile, 7500000
        • Research Site
  • Colombia
      • Bogota, Colombia, 110111
        • Research Site
      • Cali, Colombia, 760045
        • Research Site
      • Medellin, Colombia, 050010
        • Research Site
  • Costa Rica
      • San Jose, Costa Rica, 10203
        • Research Site
  • Dominican Republic
      • Santo Domingo. D.N., Dominican Republic, 10103
        • Research Site
  • Egypt
      • Alexandria, Egypt, 11591
        • Research Site
      • Cairo, Egypt, 11566
        • Research Site
      • Cairo, Egypt, 11796
        • Research Site
      • Cairo, Egypt, 11591
        • Research Site
      • Cairo, Egypt, 12611
        • Research Site
      • Luxor, Egypt, 85863
        • Research Site
  • India
      • Ahmedabad, India, 380009
        • Research Site
      • Delhi, India, 110005
        • Research Site
      • Delhi, India, 110017
        • Research Site
      • Faridabad, India, 121001
        • Research Site
      • Haryana, India, 122002
        • Research Site
      • Hyderabad, India, 500082
        • Research Site
      • Kashmir, India, 190011
        • Research Site
      • Kolkata, India, 711103
        • Research Site
      • Manipal, India, 560017
        • Research Site
      • Mumbai, India, 400012
        • Research Site
  • Kuwait
      • Kuwait City, Kuwait, 42262
        • Research Site
  • Malaysia
      • Johor Bahru, Malaysia, 80100
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Selangor, Malaysia, 47500
        • Research Site
      • Selangor, Malaysia, 68000
        • Research Site
  • Mexico
      • Ciudad de Mexico, Mexico, 06726
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
  • Panama
      • Panama City, Panama, Panama 4
        • Research Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21423
        • Research Site
      • Riyadh, Saudi Arabia, 11426
        • Research Site
      • Riyadh, Saudi Arabia, 12231
        • Research Site
  • Singapore
      • Singapore, Singapore, 119228
        • Research Site
      • Singapore, Singapore, 308433
        • Research Site
      • Singapore, Singapore, 168582
        • Research Site
  • Taiwan
      • Taichung, Taiwan, 407219
        • Research Site
      • Taipei City, Taiwan, 100225
        • Research Site
  • Turkey
      • Adana/Saricam, Turkey, 1330
        • Research Site
      • Ankara/Altindag, Turkey, 6230
        • Research Site
      • Ankara/Yenimahalle, Turkey, 6560
        • Research Site
      • Izmir/ Bornova, Turkey, 35100
        • Research Site
      • Izmir/Balcova, Turkey, 35330
        • Research Site
      • Samsun/Atakum, Turkey, 55280
        • Research Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 11001
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

with chronic lymphocytic leukemia (CLL) subjects diagnosed

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 year
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)
5 years
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
5 Years
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
5 Years
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
5 Years
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
5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recording the treatment patterns
Time Frame: 5 years
Percentage of patients who received immediate therapy and median time of observation, Number of prior lines of treatment received.
5 years
Calculation of Epidemiological Measure(s) of Interest
Time Frame: 5 Years
  • First Treatment received:
  • Number of prior lines of treatment received
5 Years
Subsequent lines of therapies
Time Frame: 5 Years

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recording the treatment-related outcomes
Time Frame: 5 years
Assessment of best response followed the IWCLL 2018 guidelines based on clinical description and biochemistry,
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8220R00031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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