Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Strategic considerations
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate effectiveness and safety in routine clinical practice in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Chronic Lymphocytic Leukemia (CLL) | Patients with diagnosed CLL and eligible to venetoclax as per label. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 24 months |
| Complete Response (CR) Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Participants currently participating (or previously participated) in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Not provided
Not provided
Not provided
Participants with diagnosed CLL and receiving venetoclax as per label.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center /ID# 207897 | Beersheba | Southern District | 8443901 | Israel | ||
| The Chaim Sheba Medical Center /ID# 207900 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
CR is defined as the proportion of participants with either CR and CRi, according to physician's assessment. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | Up to approximately 24 months |
| Ramat Gan |
| Tel Aviv |
| 5265601 |
| Israel |
| Tel Aviv Sourasky Medical Center /ID# 206962 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| HaEmek Medical Center /ID# 210900 | Afula | 1834111 | Israel |
| Rambam Health Care Campus /ID# 210320 | Haifa | 3109601 | Israel |
| Bnai Zion Medical Center /ID# 206963 | Haifa | 3339419 | Israel |
| Shaare Zedek Medical Center /ID# 207896 | Jerusalem | 91031 | Israel |
| Hadassah /ID# 207898 | Jerusalem | 91120 | Israel |
| Meir Medical Center /ID# 215466 | Kfar Saba | 4428164 | Israel |
| Galilee Medical Center /ID# 207899 | Nahariya | 2210001 | Israel |
| Rabin Medical Center /ID# 206961 | Petah Tikva | 4941492 | Israel |
| Kaplan Medical Center /ID# 207902 | Rehovot | 7661041 | Israel |
| Ziv Medical Center /ID# 215462 | Safed | 13100 | Israel |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided