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Study Venetoclax Effectiveness and Real Life Treatment Management in Participants With Chronic Lymphocytic Leukemia (VERONE)

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ClinicalTrials.gov Identifier: NCT03415035
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).

Condition or disease
Chronic Lymphocytic Leukemia (CLL)

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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Venetoclax in Chronic Lymphocytic Leukemia Effectiveness and Real-life Treatment Management
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022


Group/Cohort
Patients with Chronic Lymphocytic Leukemia (CLL)
Patients with diagnosed CLL and eligible to venetoclax as per label



Primary Outcome Measures :
  1. Best Response of Venetoclax in Participants with Chronic Lymphocytic Leukemia (CLL) up to 12 Months [ Time Frame: Up to approximately 12 months ]
    The best response is defined as the best response observed during the first year of study treatment among the possible responses to treatment: Complete Response (CR), CR with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR), Partial Response (PR), Stable Disease (SD), or Disease Progression (DP).


Secondary Outcome Measures :
  1. Time To Next Treatment [ Time Frame: Up to approximately 48 months ]
    The time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation.

  2. Time to First Response to Treatment (TTR) [ Time Frame: Up to approximately 24 months ]
    The time to response to treatment (TTR) is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented the response among CR, CRi, nPR, and PR.

  3. Minimal Residual Disease [ Time Frame: Up to approximately 24 months ]
    The proportion of participants with assessment of the minimal residual disease under venetoclax treatment (assessed by flow cytometry or Polymerase Chain Reaction).

  4. Overall Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]
    ORR is defined as the proportion of participants who reach either CR, CRi, nPR, or PR to treatment, according to physician's assessment.

  5. Change in Score of EuroQol 5 Dimensions (EQ‐5D‐5L) [ Time Frame: Up to approximately 24 months ]
    The EQ‐5D‐5L has five dimensions: mobility, self‐care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five‐level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The scores for the 5 dimensions are used to compute a single utility index score ranging from zero (0.0) to 1 (1.0) representing the general health status of the individual. The EQ‐5D‐5L also contains a visual analog scale (VAS) to assess the subject's overall health.

  6. Time to Best Response to Treatment [ Time Frame: Up to approximately 24 months ]
    The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the assessment having documented the best response among CR, CRi, nPR, PR, SD, and DP.

  7. Response Duration [ Time Frame: Up to approximately 48 months ]
    The response duration will be calculated in the sub‐population of participants experiencing treatment response (CR, CRi, nPR, or PR) from the date when response is first met to the date of first following documented progression.

  8. PFS after Disease Progression Following Venetoclax Treatment [ Time Frame: Up to approximately 48 months ]
    The PFS after disease progression following venetoclax treatment will be calculated in the sub‐population of patients experiencing disease progression under venetoclax. The PFS following venetoclax treatment is defined as the time from the date of first next CLL treatment intake to the date of the following documented progression or death from any cause.

  9. Overall survival (OS) [ Time Frame: Up to approximately 48 months ]
    OS is defined as the time from the date of first venetoclax intake to the date of death from any cause.

  10. Best Response under Next CLL Treatment [ Time Frame: Up to approximately 48 months ]
    The best response under next CLL treatment will be calculated in the sub‐population of patients having a next CLL treatment after venetoclax discontinuation.

  11. Progression‐Free Survival (PFS) [ Time Frame: Up to approximately 48 months ]
    PFS is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression or death from any cause.

  12. Time To Progression (TTP) [ Time Frame: Up to approximately 48 months ]
    The Time To Progression (TTP) is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients starting venetoclax treatment for CLL.
Criteria

Inclusion Criteria:

  • Participants with diagnosed Chronic Lymphocytic Leukemia (CLL) and eligible for venetoclax as per label.
  • Participants for whom the physician has decided to initiate CLL treatment with venetoclax.
  • Participants the physician believes he can personally follow over all the study period.
  • Participants who have been informed verbally and in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control.

Exclusion Criteria:

  • Participating in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation.

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): NCT03415035


Contacts
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Contact: Margalin Gjoklaj +33 (0) 145601187 margalin.gjoklaj@abbvie.com

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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: NCT03415035     History of Changes
Other Study ID Numbers: P16-913
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 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:
Venetoclax
Venclyxto
Cancer
Chronic Lymphocytic Leukemia (CLL)
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