Cancer, Chronic Lymphocytic Leukemia (CLL)
Conditions
Keywords
Chronic Lymphocytic Leukemia (CLL), Cancer, Observational Study, Venetoclax, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
Brief summary
This study seeks to assess the effectiveness and safety of venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) in a real-world setting across clinical practice in the Russian Federation.
Interventions
DRUGVenetoclax
tablet;oral
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a confirmed diagnosis of relapsed or refractory CLL. * Patient for whom the physician has decided to initiate CLL treatment with venetoclax (mono and combo therapy), or up to 4 weeks after venetoclax treatment initiation * Patient voluntarily agrees to participate in this study and signs informed consent form
Exclusion criteria
* Has contraindications to venetoclax as listed on the approved local label in Russian Federation. * Has Richter syndrome * Participated in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) 12 Months after Treatment Initiation | Up to approximately 12 months after treatment initiation | ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Response to Treatment | Up to approximately 24 months | The time to response to treatment is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented a response (CR, CRi, nPR, and PR). |
| 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 best response documented (CR, CRi, nPR, and PR). |
| Duration of Response (DoR) | Up to approximately 24 months | DoR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the date of disease progression or death from any cause, whichever comes first. |
| Time To Next Treatment | Up to approximately 24 months | The 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. |
| Objective Response Rate (ORR) 24 Months after Treatment Initiation | Up to approximately 24 months after treatment initiation | ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment. |
| Overall Survival (OS) Rate | Up to approximately 24 months | OS is defined as number of days from the date of first dose to the date of the observational period end or death for all dosed patients. |
| Progression-free Survival (PFS) | Up to approximately 24 months | Progression-free survival is defined as the interval between the first treatment day to the first sign of disease progression or death from any cause |
| Change from Baseline in RAND Short Form (SF)-36 Questionnaire | Up to approximately 24 months | Patient quality of life was measured by the RAND-36 health-related quality of life (HRQoL) survey instrument. This questionnaire is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. |
| Percentage of Patients with Undetectable Minimal Residual Disease (MRD) | Up to approximately 24 months | Patients will be defined as having a clinical remission in the absence of MRD when they have blood or marrow with less than one CLL cell per 10000 leucocytes. |
Countries
Russia
Outcome results
None listed