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Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real‑Life Setting

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ClinicalTrials.gov Identifier: NCT03342144
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date November 10, 2017
First Posted Date November 14, 2017
Last Update Posted Date February 28, 2019
Actual Study Start Date December 4, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2019)
Percentage of Patients Achieving Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]
ORR is defined as the percentage of participants achieving partial response (PR) and complete response with incomplete regeneration of bone marrow (CRi) and complete response (CR) according to physician's assessment to therapy with venetoclax.
Original Primary Outcome Measures
 (submitted: November 10, 2017)
Percentage of Patients Achieving Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]
ORR is defined as the percentage of participants achieving partial response (PR) or complete response (CR) according to physician's assessment to therapy with venetoclax.
Change History Complete list of historical versions of study NCT03342144 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 23, 2019)
  • Progression-Free Survival (PFS) Rate [ Time Frame: Up to 24 months ]
    Percentage of patients with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.
  • Overall Survival (OS) Rate [ Time Frame: Up to 24 months ]
    Percentage of patients with OS where OS is defined as the number of days from the date of entry in the study to the date of death.
  • EORTC QLQ-C30 Scores [ Time Frame: Up to 104 weeks ]
    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) developed to assess the quality of life of cancer patients. and is based on multi‐item and single‐item scales. The core questionnaire contains 5 functional scales, 3 symptom scales, 1 global health status scale, as well as 6 single‐item measures.
  • Percentage of Patients Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi) [ Time Frame: Up 24 months ]
    Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.
  • European Quality of Life 5 Dimensions (EQ-5D-5L) including visual analogue scale (VAS) [ Time Frame: Up 24 months ]
    The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. EQ‐5D‐5L questionnaire consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ‐5D‐5L questionnaire plus a VAS will be used to assess general health in 5 dimensions (mobility, self‐care, usual activities, pain/discomfort anxiety/depression).
  • QLQ-CLL 16/17 Scores [ Time Frame: Up to 104 weeks ]
    Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)16/17 is designed for patients with stage 0 to stage 4 chronic lymphocytic leukemia. It is used to assess 5 domains of health-related quality of life important in CLL: fatigue, side effects and symptoms of disease, infection and social activities or future illness‐related concerns.
  • Percentage of Patients with Progressive Disease (PD) [ Time Frame: Up to 24 months ]
    Progressive disease as defined in the study protocol.
  • Percentage of Patients Achieving Partial Response (PR) [ Time Frame: Up to 24 months ]
    Partial response as defined in the study protocol.
  • Percentage of Patients Administering Venetoclax [ Time Frame: Up to 24 months ]
    Percentage of patients administering venetoclax throughout the study.
  • Percentage of Patients with Stable Disease (SD) [ Time Frame: Up to 24 months ]
    SD is defined as percentage of all patients not having PD, but who do not meet the criteria for PR or CR.
  • Percentage of Patients Achieving Complete Response (CR) [ Time Frame: Up to 24 months ]
    Complete Response as defined in the study protocol.
  • Minimal Residual Disease (MRD) measurement on plasma circulating tumor Deoxyribo nucleic acid (DNA) (Switzerland Only) [ Time Frame: Up to 24 months ]
    MRD is defined as less than 1 clonal lymphocyte per 10000 leukocytes in peripheral blood or bone marrow.
  • Clonal evolution and eradication of Tumor Protein p53 (TP53) mutated clones associated with treatment in relation to MRD negativity (Switzerland Only) [ Time Frame: Up to 24 months ]
    Clonal evolution and eradication of TP53 mutated clones associated with treatment in relation to MRD negativity is evaluated
Original Secondary Outcome Measures
 (submitted: November 10, 2017)
  • Percentage of Patients Administering Venetoclax [ Time Frame: Up to 24 months ]
    Percentage of patients administering venetoclax throughout the study.
  • Progression-Free Survival (PFS) Rate [ Time Frame: Up to 24 months ]
    Percentage of patients with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.
  • Overall Survival (OS) Rate [ Time Frame: Up to 24 months ]
    Percentage of patients with OS where OS is defined as the number of days from the date of entry in the study to the date of death.
  • Percentage of Patients Achieving Complete Response (CR) [ Time Frame: Up to 24 months ]
    Complete Response as defined in the study protocol.
  • Percentage of Patients Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi) [ Time Frame: Up 24 months ]
    Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.
  • Percentage of Patients Achieving Partial Response (PR) [ Time Frame: Up to 24 months ]
    Partial response as defined in the study protocol.
  • Percentage of Patients with Progressive Disease (PD) [ Time Frame: Up to 24 months ]
    Progressive disease as defined in the study protocol.
  • Percentage of Patients with Stable Disease (SD) [ Time Frame: Up to 24 months ]
    SD is defined as percentage of all patients not having PD, but who do not meet the criteria for PR or CR.
  • EORTC QLQ-C30 Scores [ Time Frame: Up to 104 weeks ]
    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) developed to assess the quality of life of cancer patients. and is based on multi‐item and single‐item scales. The core questionnaire contains 5 functional scales, 3 symptom scales, 1 global health status scale, as well as 6 single‐item measures.
  • QLQ-CLL 16/17 Scores [ Time Frame: Up to 104 weeks ]
    Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)16/17 is designed for patients with stage 0 to stage 4 chronic lymphocytic leukemia. It is used to assess 5 domains of health-related quality of life important in CLL: fatigue, side effects and symptoms of disease, infection and social activities or future illness‐related concerns.
  • European Quality of Life 5 Dimensions (EQ-5D-5L) including visual analogue scale (VAS) [ Time Frame: Up 24 months ]
    The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. EQ‐5D‐5L questionnaire consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ‐5D‐5L questionnaire plus a VAS will be used to assess general health in 5 dimensions (mobility, self‐care, usual activities, pain/discomfort anxiety/depression).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real‑Life Setting
Official Title Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland
Brief Summary An observational study to assess the effectiveness, health economic‐relevant costs and patient reported outcomes in patients with Chronic lymphocytic leukemia (CLL) receiving venetoclax as prescribed at the discretion of the physician and in accordance with local clinical practice and label.
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 Patients with chronic lymphocytic leukemia (CLL) administering venetoclax per the local label.
Condition Chronic Lymphocytic Leukemia (CLL)
Intervention Not Provided
Study Groups/Cohorts Participants Receiving Venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
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: January 23, 2019)
250
Original Estimated Enrollment
 (submitted: November 10, 2017)
150
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient with chronic lymphocytic leukemia (CLL) administering venetoclax and who meets the following conditions as specified in the label for venetoclax:
  • Venetoclax monotherapy for the treatment of CLL in the presence of deletion chromosome 17 (del[17p]) or tumor protein p53 (TP53) mutation in adult patients, who are unsuitable for or have failed to a B‐cell receptor pathway inhibitor.
  • Venetoclax monotherapy for the treatment of CLL in the absence of del(17p) or TP53 mutation in adult patients, who have failed both chemoimmunotherapy and a B‐cell receptor pathway inhibitor.

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Johannes Huelsenbeck +49 611-1720-3036 johannes.huelsenbeck@abbvie.com
Contact: Bjoern Tews bjoern.tews@abbvie.com
Listed Location Countries Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03342144
Other Study ID Numbers P17-132
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