A Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Registration Number
- NCT03659669
- Lead Sponsor
- AbbVie
- 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 available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 272
- 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.
- Participants currently participating (or previously participated) in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) 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.
- Secondary Outcome Measures
Name Time Method Time to Response (TTR) 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.
Overall Survival (OS) 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) 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) 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 Best Response to Treatment 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.
PFS after Disease Progression Following Venetoclax Treatment 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.
Overall Response Rate (ORR) 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 Up to approximately 24 months CR is defined as the proportion of participants with either CR and CRi, according to physician's assessment.
Minimal Residual Disease 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) 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.
Time To Next Treatment 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) 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.
Best Response under Next CLL Treatment 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.
Trial Locations
- Locations (13)
Tel Aviv Sourasky Medical Center /ID# 206962
🇮🇱Tel Aviv-Yafo, Tel-Aviv, Israel
Rabin Medical Center /ID# 206961
🇮🇱Petakh Tikva, Israel
Hadassah /ID# 207898
🇮🇱Jerusalem, Israel
Meir Medical Center /ID# 215466
🇮🇱Kfar Saba, Israel
Ziv Medical Center /ID# 215462
🇮🇱Safed, Israel
Soroka University Medical Center /ID# 207897
🇮🇱Be'er Sheva, HaDarom, Israel
HaEmek Medical Center /ID# 210900
🇮🇱Afula, Israel
Rambam Health Care Campus /ID# 210320
🇮🇱Haifa, Israel
Bnai Zion Medical Center /ID# 206963
🇮🇱Haifa, Israel
The Chaim Sheba Medical Center /ID# 207900
🇮🇱Ramat Gan, Tel-Aviv, Israel
Shaare Zedek Medical Center /ID# 207896
🇮🇱Jerusalem, Israel
Galilee Medical Center /ID# 207899
🇮🇱Nahariya, Israel
Kaplan Medical Center /ID# 207902
🇮🇱Rehovot, Israel