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This study is being done to evaluate the clinical outcomes of Chronic Lymphocytic Leukemia (CLL) participants treated with venetoclax as routine standard of care in Greece. The decision to treat with venetoclax is made by the participant's physician prior to being offered enrollment in this study.
The objectives of this study include determining overall response rate, assessing safety information, analyzing patient profiles and disease characteristics and participant quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Participants | Participants for whom the treating physician has decided to treat with venetoclax before enrollment in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines and includes partial response (PR), nodular partial response (nPR), complete response with incomplete bone marrow recovery (CRi), and complete response (CR). | At Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. | Up to Month 36 |
| Complete Response (CR) | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll adult participants (age >=18) with confirmed diagnosis of Relapse/Refractory Chronic Lymphocytic Leukemia being treated with venetoclax in Greece as part of routine standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Dunnant Hospital Center /ID# 241682 | Athens | Attica | 11526 | Greece | ||
| General Hospital of Athens Gennimatas /ID# 212917 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Up to Month 36 |
| Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. | Up to Month 36 |
| Nodule Partial Response (nPR) Rate | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. | Up to Month 36 |
| Partial Response (PR) Rate | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL). | Up to Month 36 |
| Percentage of Participants With Disease Progression or Death | Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. | Up to Month 36 |
| Progression Free Survival (PFS) | Defined as the time between the date of first venetoclax intake and the date of the first assessment documenting progression or death (from any cause). | Up to Month 36 |
| Overall Survival (OS) | Defined as the time from first venetoclax intake to death from any cause. | Up to Month 36 |
| Treatment Duration | Overall treatment duration of venetoclax. | Up to Month 36 |
| Time to Progression (TTP) | Defined as the period from first venetoclax intake until objective disease progression (until disease progression or death due to progression, whichever occurs first). | Up to Month 36 |
| Change in Patient Reported Outcomes | The 5-Level EuroQol Group Questionnaire (EQ-5D-5L) is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments. | From Baseline (Week 0) Up to Month 36 |
| Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) | Determined by assessment of peripheral blood or bone marrow after treatment. | Up to Month 36 |
| Percentage of Participants with Dose Modifications | Dose modifications include interruptions during ramp-up and maintenance phase. | Up to Month 36 |
| Percentage of Participants with Adverse Drug Reactions (ADR) | ADR is defined as a response to a medicinal product that is noxious and unintended and that a causal relationship between a medicinal product and an adverse event is possible, probable or very likely as assessed by the investigator. | Up to Month 36 |
| Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia | Number of lines of prior therapy per participant, in participants with Relapse/Refractory Chronic Lymphocytic Leukemia. | Up to Month 36 |
| Athens |
| Attica |
| 11527 |
| Greece |
| General Hospital of Athens Laiko /ID# 212902 | Athens | Attica | 11527 | Greece |
| General Hospital of Athens Laiko /ID# 230222 | Athens | Attica | 11527 | Greece |
| University General Hospital Attikon /ID# 212915 | Athens | Attica | 12462 | Greece |
| Metropolitan General /ID# 212934 | Cholargós | Attica | 15562 | Greece |
| Iatriko Kentro Athinon /ID# 241689 | Marousi | Attica | 15125 | Greece |
| Iatriko Kentro Athinon /ID# 241690 | Marousi | Attica | 15125 | Greece |
| Metropolitan Hospital /ID# 241687 | Piraeus | Attica | 18547 | Greece |
| General Hospital of Chania "Agios Georgios" /ID# 241685 | Chania | Chania | 73300 | Greece |
| University General Hospital of Heraklion PA.G.N.I /ID# 212916 | Heraklion | Crete | 71500 | Greece |
| University General Hospital of Ioannina /ID# 212936 | Ioannina | Ioannina | 45500 | Greece |
| Reg Gen Univ Hosp Larissa /ID# 213708 | Larissa | Larisa | 41110 | Greece |
| Theageneio Anticancer Hospital /ID# 212933 | Thessaloniki | Thessaloniki | 54639 | Greece |
| General Hospital of Thessaloniki George Papanikolaou /ID# 213709 | Thessaloniki | Thessaloniki | 57010 | Greece |
| General University Hospital of Alexandroupolis /ID# 212927 | Alexandroupoli | 68100 | Greece |
| General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 212929 | Athens | 10676 | Greece |
| General Hospital of Patras Agios Andreas /ID# 213711 | Pátrai | 26335 | Greece |
| University Gen Hosp of Patra /ID# 212914 | Pátrai | 26504 | Greece |
| METAXA Cancer Hospital of Piraeus /ID# 212918 | Piraeus | 18737 | Greece |
| Papageorgiou General Hospital /ID# 213710 | Thessaloniki | 56429 | Greece |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
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