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Trial record 5 of 160 for:    Venetoclax AND overall

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

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ClinicalTrials.gov Identifier: NCT04159779
Recruitment Status : Not yet recruiting
First Posted : November 11, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.


Condition or disease
Chronic Lymphocytic Leukemia (CLL)

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes of Relapse/Refractory Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Routine Clinical Settings in Greece
Estimated Study Start Date : November 12, 2019
Estimated Primary Completion Date : November 12, 2023
Estimated Study Completion Date : November 12, 2023


Group/Cohort
Venetoclax Participants
Participants for whom the treating physician has decided to treat with venetoclax before enrollment in this study.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: At Month 24 ]
    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

  2. Complete Response (CR) [ Time Frame: Up to Month 24 ]
    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

  3. 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.

  4. Nodule Partial Response (nPR) Rate [ Time Frame: Up to Month 24 ]
    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

  5. Partial Response (PR) Rate [ Time Frame: Up to Month 24 ]
    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).

  6. 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.

  7. 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).

  8. Overall Survival (OS) [ Time Frame: Up to Month 24 ]
    Defined as the time from first venetoclax intake to death from any cause.

  9. Treatment Duration [ Time Frame: Up to Month 24 ]
    Overall treatment duration of venetoclax.

  10. 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).

  11. 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.

  12. 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.

  13. Percentage of Participants with Dose Modifications [ Time Frame: Up to Month 24 ]
    Dose modifications include interruptions during ramp-up and maintenance phase.

  14. 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.

  15. Number of Lines of Prior Therapy [ Time Frame: Up to Month 24 ]
    Number of lines of prior therapy per participant.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159779


Contacts
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Contact: Vagia Tsironi +30 697 4800 661 vagia.tsironi@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04159779     History of Changes
Other Study ID Numbers: P19-568
First Posted: November 11, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
Chronic Lymphocytic Leukemia (CLL)
Venetoclax
Relapsed/Refractory
Additional relevant MeSH terms:
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Venetoclax
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents