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Trial record 19 of 148 for:    Venetoclax AND Leukemia

A Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice (REVEAL)

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ClinicalTrials.gov Identifier: NCT03659669
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date September 4, 2018
First Posted Date September 6, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date February 10, 2019
Estimated Primary Completion Date October 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2018)
Overall Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]
ORR to treatment is defined as the proportion of patients with complete response (CR), Complete Response with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR) and partial response (PR), according to physician's assessment.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03659669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 4, 2018)
  • Overall Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]
    ORR to treatment is defined as the proportion of patients with complete response (CR), Complete Response with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR) or partial response (PR), according to physician's assessment.
  • Complete Response (CR) Rate [ Time Frame: Up to approximately 24 months ]
    CR is defined as the proportion of participants with either CR and CRi, according to physician's assessment.
  • Time to Response (TTR) [ Time Frame: Up to approximately 24 months ]
    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 complete response, complete response with incomplete bone marrow recovery, nodular partial response, and partial response.
  • 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, and PR.
  • Overall Survival (OS) [ Time Frame: Up to approximately 48 months ]
    Overall survival (OS) is defined as the time from the date of first venetoclax intake to the date of death from any cause.
  • 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.
  • 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.
  • Time To Next Treatment [ Time Frame: Up to approximately 48 months ]
    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.
  • Duration of Response (DOR) [ Time Frame: Up to approximately 48 months ]
    DOR is calculated in the sub-population of patients experiencing treatment response (complete response, complete response with incomplete bone marrow recovery, nodular partial response or partial response) from the date when response is first met to the date of first following documented progression.
  • PFS after Disease Progression Following Venetoclax Treatment [ Time Frame: Up to approximately 48 months ]
    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.
  • Best Response under Next CLL Treatment [ Time Frame: Up to approximately 48 months ]
    The best response under next CLL treatment is calculated in the sub-population of participants having a next CLL treatment after venetoclax discontinuation.
  • 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).
  • 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.
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 to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice
Official Title Post Marketing Observational Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice
Brief Summary This study will evaluate effectiveness and safety in routine clinical practice in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).
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 Participants with diagnosed CLL and receiving venetoclax as per label.
Condition Chronic Lymphocytic Leukemia (CLL)
Intervention Not Provided
Study Groups/Cohorts Patients with Chronic Lymphocytic Leukemia (CLL)
Patients with diagnosed CLL and eligible to venetoclax as per label.
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: February 13, 2019)
66
Original Estimated Enrollment
 (submitted: September 4, 2018)
67
Estimated Study Completion Date October 31, 2024
Estimated Primary Completion Date October 31, 2024   (Final data collection date for primary outcome measure)
Eligibility 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 who have been informed verbally and in writing about this study, and who do not object to their data being processed or subjected to data quality control.

Exclusion Criteria:

  • Participants currently participating (or previously participated) in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hilla Banayan +972 (0) 97 90 9655 hilla.banayan@abbvie.com
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03659669
Other Study ID Numbers P19-287
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 February 2019