A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent). (VENICE II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02980731|
Recruitment Status : Active, not recruiting
First Posted : December 2, 2016
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia (CLL)||Drug: Venetoclax||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 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)|
|Actual Study Start Date :||December 13, 2016|
|Estimated Primary Completion Date :||November 11, 2020|
|Estimated Study Completion Date :||June 26, 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.
- 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.
- 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.
- 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.
- 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.
- 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 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.
- 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.
- 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.
- 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.
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): NCT02980731
|Hospital Italiano La Plata /ID# 150812|
|La Plata, Buenos Aires, Argentina, 1902|
|Cemic /Id# 150810|
|Buenos Aires, Argentina, 1431|
|Fundaleu /Id# 150811|
|Buenos Aires, Argentina, C1114AAN|
|Sanatorio Allende /ID# 150813|
|Cordoba, Argentina, 5000|
|Australia, New South Wales|
|St George Hospital /ID# 154212|
|Kogarah, New South Wales, Australia, 2217|
|Liverpool Hospital /ID# 154950|
|Liverpool, New South Wales, Australia, 2170|
|Gold Coast University Hospital /ID# 150833|
|Southport, Queensland, Australia, 4215|
|Peter MacCallum Cancer Ctr /ID# 154948|
|Melbourne, Victoria, Australia, 3000|
|Australia, Western Australia|
|Perth Blood Institute Ltd /ID# 154949|
|Nedlands, Western Australia, Australia, 6009|
|UMHAT Sv. Georgi EAD /ID# 161594|
|Plovdiv, Bulgaria, 4002|
|UMHAT Aleksandrovska /ID# 162987|
|Sofia, Bulgaria, 1431|
|UMHAT Sv. Ivan Rilski /ID# 163280|
|Sofia, Bulgaria, 1612|
|SHAT Hematologic Diseases /ID# 161592|
|Sofia, Bulgaria, 1756|
|Queen Mary Hospital /ID# 150836|
|Hong Kong, Hong Kong, 999077|
|Prince of Wales Hospital /ID# 150837|
|Sha Tin, Hong Kong|
|Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 152842|
|Budapest IX, Budapest, Hungary, 1097|
|Semmelweis Egyetem /ID# 150792|
|Budapest, Hungary, 1085|
|Centro de Investigación Clinica Chapultepec /ID# 163641|
|Morelia, Michoacan, Mexico, 58260|
|Hosp. Univ. Dr. Jose E. Gonz /ID# 150821|
|Monterrey, Nuevo Leon, Mexico, 64320|
|North Shore Hospital /ID# 157626|
|Auckland, New Zealand, 0622|
|Middlemore Clinical Trials /ID# 161526|
|Auckland, New Zealand, 2025|
|Wellington Regional Hospital /ID# 157627|
|Newtown Wellington, New Zealand, 6021|
|Zespol Szpitali Miejskich /ID# 150877|
|Chorzow, Poland, 41-500|
|Szpitale Pomorskie Sp. z o.o /ID# 164097|
|Gdynia, Poland, 81-519|
|Wojewodzkie Wielospecjalistycz /ID# 150880|
|Lodz, Poland, 93-509|
|Instytut Hematologii i Transfu /ID# 150878|
|Warsaw, Poland, 02-776|
|NN Blokhin Russian Cancer /ID# 166610|
|Moscow, Moskva, Russian Federation, 115478|
|Moscow State budget healthcare institution City Clinical Hospital n.a. Botkin /ID# 154806|
|Moscow, Moskva, Russian Federation, 125284|
|Federal State Budgetary Ins"NRC for Hematology" of MoH of Russian Federation /ID# 154213|
|Moscow, Russian Federation, 125167|
|Penza Regional Cancer Center /ID# 154202|
|Penza, Russian Federation, 440071|
|China Medical University Hosp /ID# 150839|
|Taichung City, Taichung, Taiwan, 40447|
|National Taiwan Univ Hosp /ID# 150838|
|Taipei City, Taipei, Taiwan, 10002|
|Taipei Veterans General Hosp /ID# 153803|
|Taipei City, Taiwan, 11217|
|Study Director:||AbbVie Inc.||AbbVie|