## Protocol Section
### Identification Module
**NCT ID:** NCT04159779

**Brief Title:** A Study of Clinical Outcomes in Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Greece

**Official Title:** Clinical Outcomes of Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Routine Clinical Settings in Greece

#### Organization Study ID Info
**ID:** P19-568
#### Organization
**Class:** INDUSTRY
**Full Name:** AbbVie
### Status Module
#### Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-14

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-10

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-01-13

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2019-11-12
**Type:** ACTUAL
**Study First Submit Date:** 2019-11-08
**Study First Submit QC Date:** 2019-11-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AbbVie

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Chronic Lymphocytic Leukemia

**Keywords:**

- Chronic Lymphocytic Leukemia Venetoclax Relapsed/Refractory

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 180

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants for whom the treating physician has decided to treat with venetoclax before enrollment in this study.

**Label:** Venetoclax Participants

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Overall Response Rate (ORR)

**Time Frame:** At Month 12

#### Secondary Outcomes

**Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

**Measure:** Overall Response Rate (ORR)

**Time Frame:** Up to Month 36

**Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

**Measure:** Complete Response (CR)

**Time Frame:** Up to Month 36

**Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

**Measure:** Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate

**Time Frame:** Up to Month 36

**Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

**Measure:** Nodule Partial Response (nPR) Rate

**Time Frame:** Up to Month 36

**Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).

**Measure:** Partial Response (PR) Rate

**Time Frame:** Up to Month 36

**Description:** Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

**Measure:** Percentage of Participants With Disease Progression or Death

**Time Frame:** Up to Month 36

**Description:** 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).

**Measure:** Progression Free Survival (PFS)

**Time Frame:** Up to Month 36

**Description:** Defined as the time from first venetoclax intake to death from any cause.

**Measure:** Overall Survival (OS)

**Time Frame:** Up to Month 36

**Description:** Overall treatment duration of venetoclax.

**Measure:** Treatment Duration

**Time Frame:** Up to Month 36

**Description:** Defined as the period from first venetoclax intake until objective disease progression (until disease progression or death due to progression, whichever occurs first).

**Measure:** Time to Progression (TTP)

**Time Frame:** Up to Month 36

**Description:** 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.

**Measure:** Change in Patient Reported Outcomes

**Time Frame:** From Baseline (Week 0) Up to Month 36

**Description:** Determined by assessment of peripheral blood or bone marrow after treatment.

**Measure:** Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)

**Time Frame:** Up to Month 36

**Description:** Dose modifications include interruptions during ramp-up and maintenance phase.

**Measure:** Percentage of Participants with Dose Modifications

**Time Frame:** Up to Month 36

**Description:** 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.

**Measure:** Percentage of Participants with Adverse Drug Reactions (ADR)

**Time Frame:** Up to Month 36

**Description:** Number of lines of prior therapy per participant, in participants with Relapse/Refractory Chronic Lymphocytic Leukemia.

**Measure:** Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia

**Time Frame:** Up to Month 36

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
* Eligible to receive venetoclax as per local label
* Physician has decided to initiate CLL treatment with venetoclax and the decision to treat is made by the physician in accordance with the local label prior to any decision to approach the participant about the study
* Participant has been fully informed verbally and in writing about the study and does not object to their data being processed or subjected to data quality control

Exclusion Criteria:

* Prescribed or treated with venetoclax outside of marketing authorization
* Currently participating in, or previously participated within 30 days prior to venetoclax start, in any other interventional clinical trial

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Athens

**Country:** Greece

**Facility:** Henry Dunnant Hospital Center /ID# 241682

**State:** Attiki

**Zip:** 11526

**Location 2:**

**City:** Athens

**Country:** Greece

**Facility:** General Hospital of Athens Gennimatas /ID# 212917

**State:** Attiki

**Zip:** 11527

**Location 3:**

**City:** Athens

**Country:** Greece

**Facility:** General Hospital of Athens Laiko /ID# 212902

**State:** Attiki

**Zip:** 11527

**Location 4:**

**City:** Athens

**Country:** Greece

**Facility:** General Hospital of Athens Laiko /ID# 230222

**State:** Attiki

**Zip:** 11527

**Location 5:**

**City:** Athens

**Country:** Greece

**Facility:** University General Hospital Attikon /ID# 212915

**State:** Attiki

**Zip:** 12462

**Location 6:**

**City:** Cholargos

**Country:** Greece

**Facility:** Metropolitan General /ID# 212934

**State:** Attiki

**Zip:** 15562

**Location 7:**

**City:** Marousi

**Country:** Greece

**Facility:** Iatriko Kentro Athinon /ID# 241689

**State:** Attiki

**Zip:** 15125

**Location 8:**

**City:** Marousi

**Country:** Greece

**Facility:** Iatriko Kentro Athinon /ID# 241690

**State:** Attiki

**Zip:** 15125

**Location 9:**

**City:** Piraeus

**Country:** Greece

**Facility:** Metropolitan Hospital /ID# 241687

**State:** Attiki

**Zip:** 18547

**Location 10:**

**City:** Heraklion

**Country:** Greece

**Facility:** University General Hospital of Heraklion PA.G.N.I /ID# 212916

**State:** Kriti

**Zip:** 71500

**Location 11:**

**City:** Stavroupoli (Thessalonikis)

**Country:** Greece

**Facility:** Papageorgiou General Hospital Thessaloniki /ID# 213710

**State:** Thessaloniki

**Zip:** 55536

**Location 12:**

**City:** Alexandroupolis

**Country:** Greece

**Facility:** General University Hospital of Alexandroupolis /ID# 212927

**Zip:** 68100

**Location 13:**

**City:** Athens

**Country:** Greece

**Facility:** General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 212929

**Zip:** 10676

**Location 14:**

**City:** Chania

**Country:** Greece

**Facility:** General Hospital of Chania "Agios Georgios" /ID# 241685

**Zip:** 73300

**Location 15:**

**City:** Ioannina

**Country:** Greece

**Facility:** University General Hospital of Ioannina /ID# 212936

**Zip:** 45500

**Location 16:**

**City:** Larisa

**Country:** Greece

**Facility:** Reg Gen Univ Hosp Larissa /ID# 213708

**Zip:** 41110

**Location 17:**

**City:** Patras

**Country:** Greece

**Facility:** General Hospital of Patras Agios Andreas /ID# 213711

**Zip:** 26335

**Location 18:**

**City:** Patras

**Country:** Greece

**Facility:** University Gen Hosp of Patra /ID# 212914

**Zip:** 26504

**Location 19:**

**City:** Piraeus

**Country:** Greece

**Facility:** METAXA Cancer Hospital of Piraeus /ID# 212918

**Zip:** 18737

**Location 20:**

**City:** Thessaloniki

**Country:** Greece

**Facility:** Theageneio Anticancer Hospital /ID# 212933

**Zip:** 54639

**Location 21:**

**City:** Thessaloniki

**Country:** Greece

**Facility:** General Hospital of Thessaloniki George Papanikolaou /ID# 213709

**Zip:** 57010

#### Overall Officials

**Official 1:**

**Affiliation:** AbbVie

**Name:** ABBVIE INC.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### See Also Links

**Label:** Related Info

**URL:** https://www.rxabbvie.com/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000015448

- Term: Leukemia, B-Cell

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10951

- Name: Leukemia, Lymphoid

- Relevance: HIGH

- As Found: Lymphocytic Leukemia

- ID: M18116

- Name: Leukemia, Lymphocytic, Chronic, B-Cell

- Relevance: HIGH

- As Found: Chronic Lymphocytic Leukemia

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18115

- Name: Leukemia, B-Cell

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1308

- Name: Chronic Lymphocytic Leukemia

- Relevance: HIGH

- As Found: Chronic Lymphocytic Leukemia

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000007945

- Term: Leukemia, Lymphoid

- ID: D000015451

- Term: Leukemia, Lymphocytic, Chronic, B-Cell

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M249656

- Name: Venetoclax

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
