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

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

Study Description

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)

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

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Sponsors and Collaborators

AbbVie

Investigators

• Study Director: AbbVie Inc.; AbbVie

More Information

Additional Information:

Related Info 

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03415035 History of Changes
• Other Study ID Numbers: P16-913
• First Posted: January 30, 2018
• Last Update Posted: August 29, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

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