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A Study of Clinical Outcomes in Relapse/Refractory Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Greece

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159779
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date November 8, 2019
First Posted Date November 12, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date January 13, 2020
Estimated Primary Completion Date November 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2019)
Overall Response Rate (ORR) [ Time Frame: At Month 12 ]
Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines and includes partial response (PR), nodular partial response (nPR), complete response with incomplete bone marrow recovery (CRi), and complete response (CR).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 8, 2019)
  • Overall Response Rate (ORR) [ Time Frame: At Month 24 ]
    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Complete Response (CR) [ Time Frame: Up to Month 24 ]
    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate [ Time Frame: Up to Month 24 ]
    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Nodule Partial Response (nPR) Rate [ Time Frame: Up to Month 24 ]
    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Partial Response (PR) Rate [ Time Frame: Up to Month 24 ]
    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
  • Percentage of Participants With Disease Progression or Death [ Time Frame: Up to Month 24 ]
    Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Progression Free Survival (PFS) [ Time Frame: Up to Month 24 ]
    Defined as the time between the date of first venetoclax intake and the date of the first assessment documenting progression or death (from any cause).
  • Overall Survival (OS) [ Time Frame: Up to Month 24 ]
    Defined as the time from first venetoclax intake to death from any cause.
  • Treatment Duration [ Time Frame: Up to Month 24 ]
    Overall treatment duration of venetoclax.
  • Time to Progression (TTP) [ Time Frame: Up to Month 24 ]
    Defined as the period from first venetoclax intake until objective disease progression (until disease progression or death due to progression, whichever occurs first).
  • Change in Patient Reported Outcomes [ Time Frame: From Baseline (Week 0) Up to Month 24 ]
    The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
  • Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) [ Time Frame: Up to Month 24 ]
    Determined by assessment of peripheral blood or bone marrow after treatment.
  • Percentage of Participants with Dose Modifications [ Time Frame: Up to Month 24 ]
    Dose modifications include interruptions during ramp-up and maintenance phase.
  • Percentage of Participants with Adverse Drug Reactions (ADR) [ Time Frame: Up to Month 24 ]
    ADR is defined as a response to a medicinal product that is noxious and unintended and that a causal relationship between a medicinal product and an adverse event is possible, probable or very likely as assessed by the investigator.
  • Number of Lines of Prior Therapy [ Time Frame: Up to Month 24 ]
    Number of lines of prior therapy per participant.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Clinical Outcomes in Relapse/Refractory Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Greece
Official Title Clinical Outcomes of Relapse/Refractory Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Routine Clinical Settings in Greece
Brief Summary

This study is being done to evaluate the clinical outcomes of Relapse/Refractory Chronic Lymphocytic Leukemia (CLL) participants treated with venetoclax as routine standard of care in Greece. The decision to treat with venetoclax is made by the participant's physician prior to being offered enrollment in this study.

The objectives of this study include determining overall response rate, assessing safety information, analyzing patient profiles and disease characteristics and participant quality of life.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will enroll adult participants (age >=18) with confirmed diagnosis of Relapse/Refractory Chronic Lymphocytic Leukemia being treated with venetoclax in Greece as part of routine standard of care.
Condition Chronic Lymphocytic Leukemia (CLL)
Intervention Not Provided
Study Groups/Cohorts Venetoclax Participants
Participants for whom the treating physician has decided to treat with venetoclax before enrollment in this study.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 8, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 25, 2020
Estimated Primary Completion Date November 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
  • Eligible to receive venetoclax as per local label
  • Physician has decided to initiate CLL treatment with venetoclax and the decision to treat is made by the physician in accordance with the local label prior to any decision to approach the participant about the study
  • Participant has been fully informed verbally and in writing about the study and does not object to their data being processed or subjected to data quality control

Exclusion Criteria:

  • Prescribed or treated with venetoclax outside of marketing authorization
  • Currently participating in, or previously participated within 30 days prior to venetoclax start, in any other interventional clinical trial
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Vagia Tsironi +30 697 4800 661 vagia.tsironi@abbvie.com
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT04159779
Other Study ID Numbers P19-568
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date January 2020