A Study Evaluating Venetoclax in Subjects With Chronic Lymphocytic Leukemia Whose Cancer Has Come Back or Who Had No Response to Previous Cancer Treatments Including Subjects Missing Part of Their Chromosome 17, or TP53 Gene Mutation; or Who Received Prior Treatment With a B-Cell Receptor Inhibitor
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|ClinicalTrials.gov Identifier: NCT02980731|
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia (CLL)||Drug: Venetoclax||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) Including Those With the 17p Deletion or TP53 Mutation OR Those Who Have Received Prior Treatment With B-Cell Receptor Inhibitor|
|Study Start Date :||December 13, 2016|
|Estimated Primary Completion Date :||November 11, 2020|
|Estimated Study Completion Date :||November 15, 2022|
Venetoclax will be administered orally 20 mg once daily (QD) beginning with a dose-titration phase, and then escalated up to 400 mg QD.
Other Name: ABT-199
- Change in Global Health Status/Quality of Life (GHS/QoL) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) [ Time Frame: From Screening (Baseline) up to Week 48 ]EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small. A change of 10 - 20 points is considered a moderate change.
- Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16), [ Time Frame: From Screening (Baseline; Day 0) up to Week 48 ]EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of HRQoL important in CLL. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much." A negative change in score from baseline represents an improvement in symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
- EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) [ Time Frame: From Screening (Baseline; Day 0) up to Week 48 ]The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a 5-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.
- Change in the remaining subscales/items from the EORTC QLQ-C30. [ Time Frame: From Screening (Baseline; Day 0) up to Week 48 ]The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and difficulties). Subjects rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
- Complete Remission rate (complete remission [CR] + complete remission with incomplete marrow recovery [CRi]) [ Time Frame: When all participants have completed Week 48 disease assessment, or after all enrolled participants have discontinued venetoclax, whichever is earlier. ]Complete remission rate (CR + CRi) defined as the proportion of subjects achieving a CR or CRi as their best response (per the investigator assessment) based on IWCLL NCI -WG criteria.
- Overall Response Rate (ORR) [ Time Frame: Measured up to 2 years after the last participant has enrolled in the study. ]ORR assessed as the proportion of participants with an overall response (CR + CRi + Nodular Partial Remission [nPR] + Partial Remission [PR]) based on the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group Guidelines (IWCLL NCI-WG) criteria.
- Duration of Overall Response (DOR) [ Time Frame: Measured up to 2 years after the last participant has enrolled in the study. ]DoR is defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the earliest recurrence or progressive disease.
- Time to Progression (TTP) [ Time Frame: Measured up to 2 years after the last participant has enrolled in the study. ]TPP defined as the number of days from the date of first dose of venetoclax to the date of disease progression.
- Duration of Progression-Free Survival (PFS) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]PFS defined as the number of days from the date of first dose of venetoclax to the date of disease progression or death, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]OS defined as number of days from the date of first dose of venetoclax to the date of death for all dosed participants.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980731
|Contact: AbbVie_Call Centerfirstname.lastname@example.org|
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|Study Director:||Viktor Komlosi, MD||AbbVie|