This study will evaluate effectiveness and safety in routine clinical practice in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).
Study Type
OBSERVATIONAL
Enrollment
272
Soroka University Medical Center /ID# 207897
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 207900
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 206962
Tel Aviv, Tel Aviv, Israel
Overall Response Rate (ORR)
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.
Time frame: Up to approximately 12 months
Overall Response Rate (ORR)
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.
Time frame: Up to approximately 24 months
Complete Response (CR) Rate
CR is defined as the proportion of participants with either CR and CRi, according to physician's assessment.
Time frame: Up to approximately 24 months
Time to Response (TTR)
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 frame: Up to approximately 24 months
Time to Best Response to Treatment
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.
Time frame: Up to approximately 24 months
Overall Survival (OS)
Overall survival (OS) is defined as the time from the date of first venetoclax intake to the date of death from any cause.
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HaEmek Medical Center /ID# 210900
Afula, Israel
Rambam Health Care Campus /ID# 210320
Haifa, Israel
Bnai Zion Medical Center /ID# 206963
Haifa, Israel
Shaare Zedek Medical Center /ID# 207896
Jerusalem, Israel
Hadassah /ID# 207898
Jerusalem, Israel
Meir Medical Center /ID# 215466
Kfar Saba, Israel
Galilee Medical Center /ID# 207899
Nahariya, Israel
...and 3 more locations
Time frame: Up to approximately 48 months
Time To Progression (TTP)
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.
Time frame: Up to approximately 48 months
Progression-Free Survival (PFS)
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 frame: Up to approximately 48 months
Time To Next Treatment
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.
Time frame: Up to approximately 48 months
Duration of Response (DOR)
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.
Time frame: Up to approximately 48 months
PFS after Disease Progression Following Venetoclax Treatment
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.
Time frame: Up to approximately 48 months
Best Response under Next CLL Treatment
The best response under next CLL treatment is calculated in the sub-population of participants having a next CLL treatment after venetoclax discontinuation.
Time frame: Up to approximately 48 months
Minimal Residual Disease
The proportion of participants with assessment of the minimal residual disease under venetoclax treatment (assessed by flow cytometry or Polymerase Chain Reaction).
Time frame: Up to approximately 24 months
Change in Score of EuroQol 5 Dimensions (EQ-5D-5L)
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 frame: Up to approximately 24 months