## Protocol Section
### Identification Module
**NCT ID:** NCT05555979

**Acronym:** ELECTRIC

**Brief Title:** A Study to Assess Change in Patient Experience in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets + Intravenous Rituximab or Bruton's Tyrosine Kinase Inhibitors Tablets in the United Kingdom

**Official Title:** Qualitative, Cross-sectional Observational Study Exploring the Experience of Patients Prescribed Venetoclax+Rituximab or Bruton's Tyrosine Kinase Inhibitors for Chronic Lymphocytic Leukaemia in Clinical Practice in the UK

#### Organization Study ID Info
**ID:** P23-486
#### Organization
**Class:** INDUSTRY
**Full Name:** AbbVie
### Status Module
#### Completion Date
**Date:** 2024-04-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-10

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2022-09-27
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-23
**Study First Submit QC Date:** 2022-09-23
### 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:** Chronic lymphocytic leukemia (CLL), a form of Non-Hodgkin's Lymphoma, is the most common type of leukemia in adults, affecting approximately 3,800 people in the UK each year. This study will evaluate the patient experience of CLL in adult participants who are prescribed venetoclax+rituximab or Bruton's tyrosine kinase inhibitors in the United Kingdom (UK).

Venetoclax+rituximab is a drug approved to treat CLL. Study participants will receive venetoclax+rituximab as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed venetoclax+rituximab or Bruton's tyrosine kinase inhibitors will be enrolled. Around 140 participants will be enrolled in the study in approximately 10 sites in the UK.

Participants will receive venetoclax tablets to be taken by mouth and rituximab intravenous (IV) injection according to the approved local label.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.

### Conditions Module

**Conditions:**

- Chronic Lymphocytic Leukemia

**Keywords:**

- Chronic Lymphocytic Leukemia

- Rituximab

- Bruton's Tyrosine Kinase Inhibitor

- Venetoclax

- Venclexta

- Venclyxto

- ABT-199

- Cancer

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants treated with venetoclax+rituximab or bruton's tyrosine kinase inhibitors in accordance with approved local label.

**Label:** Chronic Lymphocytic Leukemia (CLL) Participants

### Outcomes Module

#### Primary Outcomes

**Description:** Number of participants who report a change in CLL symptoms through qualitative interviews.

**Measure:** Number of Participants with a Change in Chronic Lymphocytic Leukemia (CLL) Symptoms

**Time Frame:** Day 1

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) (as defined by 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group (IWCLL NCI-WG) Guidelines).
* Has relapsed/refractory (R/R) disease having received only 1 prior line of treatment, which must have been a chemotherapy or chemoimmunotherapy treatment.
* Has treatment experience with venetoclax+rituximab (Ven+R) or bruton's tyrosine kinase inhibitor (BTKi)s that meets the criteria for inclusion described in the protocol, for which recruitment targets have not yet been met.

Exclusion Criteria:

* Previously treated with a BTKi, a BCL-2 inhibitor or other investigational agents.
* Has any other medical condition or disorder that, in the opinion of the site investigator or study director, could compromise participant's ability to give written informed consent and/or prevent or interfere with his or her ability to comply with study procedures and provide meaningful information about his or her CLL experience.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult participants with second-line (2L) chronic lymphocytic leukemia (CLL) treated with venetoclax+rituximab or bruton's tyrosine kinase inhibitors per approved local label in the United Kingdom.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** London

**Country:** United Kingdom

**Facility:** Barts Health NHS Trust /ID# 252717

**State:** London, City Of

**Zip:** E1 2ES

**Location 2:**

**City:** Norwich

**Country:** United Kingdom

**Facility:** Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252720

**State:** Norfolk

**Zip:** NR4 7UY

**Location 3:**

**City:** Nottingham

**Country:** United Kingdom

**Facility:** Nottingham City Hospital /ID# 252716

**State:** Nottinghamshire

**Zip:** NG5 1PB

**Location 4:**

**City:** Oxford

**Country:** United Kingdom

**Facility:** Oxford University Hospitals NHS Foundation Trust /ID# 252715

**State:** Oxfordshire

**Zip:** OX3 9DU

**Location 5:**

**City:** Worthing

**Country:** United Kingdom

**Facility:** University Hospitals Sussex NHS Foundation Trust /ID# 252672

**State:** West Sussex

**Zip:** BN11 2DH

**Location 6:**

**City:** Leicester

**Country:** United Kingdom

**Facility:** University Hospitals of Leicester NHS Trust /ID# 252719

**Zip:** LE1 5WW

**Location 7:**

**City:** London

**Country:** United Kingdom

**Facility:** The Royal Marsden NHS Foundation Trust /ID# 252655

**Zip:** SW3 6JJ

**Location 8:**

**City:** Portsmouth

**Country:** United Kingdom

**Facility:** Portsmouth Hospitals University NHS Trust /ID# 252722

**Zip:** PO6 3LY

**Location 9:**

**City:** Sunderland

**Country:** United Kingdom

**Facility:** Sunderland Royal Hospital /ID# 252495

**Zip:** SR4 7TN

**Location 10:**

**City:** Taunton

**Country:** United Kingdom

**Facility:** Taunton and Somerset NHS Foundation Trust /ID# 252721

**Zip:** TA1 5DA

#### 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

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### 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

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M249656

- Name: Venetoclax

- Relevance: LOW

- As Found: Unknown

- ID: M373

- Name: Rituximab

- Relevance: LOW

- As Found: Unknown

- ID: M2889

- Name: Tyrosine Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T22

- Name: Tyrosine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
