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A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) (VENICE I)

Primary Purpose

Chronic Lymphocytic Leukemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Venetoclax

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Oncology, Chronic Lymphocytic Leukemia, 17p Deletion, TP53 Mutation, Relapsed, Refractory, B-Cell receptor inhibitor

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant has Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
Participant has relapsed/refractory disease (received at least 1 prior therapy)
Participant has diagnosis of CLL that meets published 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group (IWCLL NCI-WG) Guidelines and:
- has an indication for treatment according to the 2008 Modified IWCLL NCI-WG criteria
- has clinically measurable disease (lymphocytosis greater than 5 × 10^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)
In addition, participants:
- with or without 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or peripheral blood AND/OR
- may have been previously treated with a prior B-cell receptor inhibitor
Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening

Exclusion Criteria:

Participant has developed Richter's transformation or Prolymphocytic leukemia
Participant has previously received venetoclax
History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of:
- adequately treated in situ carcinoma of the cervix uteri
- adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
- previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura despite low dose corticosteroids
Participant has undergone an allogeneic stem cell transplant
Treatment with any of the following within five half-lives or 14 days (if half-life unknown) as applicable prior to the first dose of venetoclax, or clinically significant adverse effect(s)/toxicity(s) of the previous therapy have not resolved to < National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 Grade 2:
- Any anti-cancer therapy including chemotherapy, or radiotherapy;
- Investigational therapy, including targeted small molecule agents
Participant is human immunodeficiency virus (HIV) positive
Participant has known allergy to both xanthine oxidase inhibitors and rasburicase

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venetoclax

Arm Description

Venetoclax will be administered orally once daily (QD) beginning with a dose-titration phase. The initial venetoclax dose is 20 mg QD. After 1 week of treatment at 20 mg QD, the dose will be escalated to 50 mg QD followed by subsequent increases, each after 1 week, to 100 mg QD, 200 mg QD and the maximum dose of 400 mg QD. Participants may continue to receive venetoclax for up to 2 years provided they continue to tolerate the drug, have no evidence of disease progression (based on investigator's assessment), do not have unacceptable toxicity, and do not meet any of the criteria for discontinuation. In countries where venetoclax is not commercially available, participants who continue to derive benefit after 2 years of treatment may be able to extend their treatment for up to 2 additional years, plus one additional year until the venetoclax extension study was open, determined on a case by case basis.

Outcomes

Primary Outcome Measures

Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis

Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria. CR required all of the following: Peripheral blood lymphocytes < 4000/μL Absence of lymphadenopathy by physical examination and computed tomography scan No hepatomegaly or splenomegaly by physical examination Absence of disease or constitutional symptoms (unexplained fevers > 38°C, drenching night sweats, > 10% weight loss in last 6 months) Blood counts above the following: Neutrophils > 1500/μL Platelets > 100,000/μL Hemoglobin > 110 g/L Bone marrow at least normocellular for age, < 30% lymphocytes. CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity.

Secondary Outcome Measures

Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Primary Analysis

Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following: Peripheral blood lymphocytes < 4000/μL Absence of lymphadenopathy by physical examination and computed tomography scan No hepatomegaly or splenomegaly by physical examination Absence of disease or constitutional symptoms (unexplained fevers > 38°C, drenching night sweats, > 10% weight loss in last 6 months) Blood counts above the following: Neutrophils > 1500/μL Platelets > 100,000/μL Hemoglobin > 110 g/L Bone marrow at least normocellular for age, < 30% lymphocytes CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity.

Overall Response Rate (ORR) - Primary Analysis

Overall response rate was defined as the percentage of participants with an overall best response of CR, CRi, nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 modified IWCLL NCI-WG criteria assessed by the investigator. CR and CRi are defined above. nPR is defined as for CR but bone marrow nodules could be identified histologically. For PR at least 2 of the following must be met: 50% decrease in peripheral blood lymphocyte count from the Baseline value; 50% reduction in lymphadenopathy; 50% reduction in the size of the liver and/or spleen (if abnormal prior to therapy); In addition at least 1 of the following criteria must be met: Neutrophils > 1,500/μL or ≥ 50% improvement over Baseline; Platelets > 100,000/μL or ≥ 50% improvement over Baseline; Hemoglobin > 11.0 g/dL or ≥ 50% improvement over Baseline without transfusions or exogenous growth factors. PR must have been confirmed at least 7 weeks later.

Duration of Overall Response (DOR) - Primary Analysis

Duration of response was defined as the time from the date of first response (CR, CRi, nPR, or PR) to the earliest date that progressive disease (PD) was objectively documented (radiographic or clinical) or death. Duration of response was analyzed by Kaplan-Meier (K-M) methodology. If a participant was still responding the data were censored at the date of the last available disease assessment prior to the data cutoff date.

Time to Progression (TTP) - Primary Analysis

Time to progression was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical). Participants who did not experience disease progression were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline disease assessments were censored at the first dose date plus 1 day. Time to progression was estimated using Kaplan-Meier methodology.

Progression-Free Survival (PFS) - Primary Analysis

Progression-free survival (PFS) was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical) or death. Participants who did not experience disease progression or death were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline tumor assessment or clinical assessment for progression were censored at the date of first dose plus 1 day. Progression-free survival was analyzed by Kaplan-Meier methodology.

Overall Survival (OS) - Primary Analysis

Overall survival (time to death) was defined as the time from the first dose date of venetoclax to the date of death. If a participant had not died the data were censored at the date when they were last known to be alive prior to the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.

Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu)

The FACT-Leu is a 44-item, leukemia-specific questionnaire designed to assess health-related quality of life (HRQoL) and leukemia-specific symptoms using a core set of questions (Functional Assessment of Cancer Therapy-General; FACT-G), and a cancer site-specific leukemia subscale. Questions are scored on a scale from 0 (not at all) to 4 (very much). FACT-G consists of 27 general items divided into 4 primary HRQoL domains: Physical Well-being (PWB; 7 items; score range 0-28), Social/Family Well-being (SWB; 7 items; score range 0-28), Emotional Well-being (EWB; 6 items; score range 0-24), Functional Well-being (FWB; 7 items; score range 0-28). The leukemia subscale consists of 17 items (score range 0-68) that assess patient concerns relating to leukemia. Three summary scales were calculated: FACT-Trial Outcome Index composed of the PWB, FWB, and leukemia subscale (score range 0-124); FACT-G (score range 0-108) and the FACT-Leu Total (range 0-176). Higher scores reflect better HRQoL.

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)

The FACIT-Fatigue questionnaire measures fatigue and its effect on functioning and daily activities. The FACIT-Fatigue includes 13 items answered on a 5-point rating scale based on a 7-day recall period. Scores range from 0 to 52, with lower scores reflecting greater fatigue.

Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Health Index Score

The EQ-5D-5L is a generic measure of health status consisting of two parts: a descriptive system consisting of 5 items and a visual analog scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participant is asked to rate each dimension on 5 levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). The scores for the 5 dimensions are used to compute a single health utility index score representing the general health status of the individual. The health index score ranges from zero (defined as a health state equivalent to being dead) to 1 (full health).

Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Visual Analog Scale Score

The EQ-5D-5L is a generic measure of health status consisting of two parts, a descriptive system consisting of 5 items and a visual analog scale (VAS). The VAS assesses the participant's self-rated overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).

Full Information

NCT ID

NCT02756611

First Posted

April 26, 2016

Last Updated

April 7, 2023

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02756611

Brief Title

A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)

Acronym

VENICE I

Official Title

Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT 199) in Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

June 22, 2016 (Actual)

Primary Completion Date

April 10, 2019 (Actual)

Study Completion Date

March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment with a B-cell receptor inhibitor.

Detailed Description

Following the Screening period, all eligible participants initiate venetoclax on a once daily (QD) dosing schedule. To mitigate the risk for tumor lysis syndrome (TLS), dosing will start with a 5-week dose titration phase. Participants may receive venetoclax for up to 2 years provided they continue to tolerate the drug, have no evidence of disease progression (based on investigator assessment), do not have unacceptable toxicity and do not meet any of the criteria for subject discontinuation. In countries where venetoclax is not commercially available, participants who continued to derive benefit after 2 years of treatment may extend their treatment for up to 2 additional years in an extended access phase. Participants in the extended access phase of this study who continue to derive benefit from venetoclax after the 2-year extension and are transferring to the venetoclax extension study, Study M19-388 (NCT03844048), may remain in Extended Access for up to 1 additional year or until the extension study is approved and initiated at the site, whichever is sooner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia

Keywords

Oncology, Chronic Lymphocytic Leukemia, 17p Deletion, TP53 Mutation, Relapsed, Refractory, B-Cell receptor inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

258 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Venetoclax

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Venetoclax

Other Intervention Name(s)

ABT-199, VENCLEXTA®

Intervention Description

Tablets for oral administration

Primary Outcome Measure Information:

Title

Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis

Description

Time Frame

From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Secondary Outcome Measure Information:

Title

Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Primary Analysis

Description

Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following: Peripheral blood lymphocytes < 4000/μL Absence of lymphadenopathy by physical examination and computed tomography scan No hepatomegaly or splenomegaly by physical examination Absence of disease or constitutional symptoms (unexplained fevers > 38°C, drenching night sweats, > 10% weight loss in last 6 months) Blood counts above the following: Neutrophils > 1500/μL Platelets > 100,000/μL Hemoglobin > 110 g/L Bone marrow at least normocellular for age, < 30% lymphocytes CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity.

Time Frame

From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Title

Overall Response Rate (ORR) - Primary Analysis

Description

Time Frame

From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Title

Duration of Overall Response (DOR) - Primary Analysis

Description

Time Frame

From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Title

Time to Progression (TTP) - Primary Analysis

Description

Time Frame

From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Title

Progression-Free Survival (PFS) - Primary Analysis

Description

Time Frame

From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Title

Overall Survival (OS) - Primary Analysis

Description

Time Frame

From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Title

Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu)

Description

Time Frame

Baseline and Weeks 48 and 108

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)

Description

Time Frame

Baseline and Weeks 48 and 108

Title

Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Health Index Score

Description

Time Frame

Baseline and Weeks 48 and 108

Title

Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Visual Analog Scale Score

Description

Time Frame

Baseline and Weeks 48 and 108

Other Pre-specified Outcome Measures:

Title

Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Final Analysis

Description

Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following: Peripheral blood lymphocytes < 4000/μL Absence of lymphadenopathy by physical examination and computed tomography scan No hepatomegaly or splenomegaly by physical examination Absence of disease or constitutional symptoms (unexplained fevers > 38°C, drenching night sweats, > 10% weight loss in last 6 months) Blood counts above the following: Neutrophils > 1500/μL Platelets > 100,000/μL Hemoglobin > 110 g/L Bone marrow at least normocellular for age, < 30% lymphocytes. CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity.

Time Frame

From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Title

Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Final Analysis

Description

Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following: Peripheral blood lymphocytes < 4000/μL Absence of lymphadenopathy by physical examination and computed tomography scan No hepatomegaly or splenomegaly by physical examination Absence of disease or constitutional symptoms (unexplained fevers > 38°C, drenching night sweats, > 10% weight loss in last 6 months) Blood counts above the following: Neutrophils > 1500/μL Platelets > 100,000/μL Hemoglobin > 110 g/L Bone marrow at least normocellular for age, < 30% lymphocytes CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity.

Time Frame

From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Title

Overall Response Rate (ORR) - Final Analysis

Description

Time Frame

From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Title

Duration of Overall Response (DOR) - Final Analysis

Description

Time Frame

From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Title

Time to Progression (TTP) - Final Analysis

Description

Time Frame

From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Title

Progression-Free Survival (PFS) - Final Analysis

Description

Time Frame

From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Title

Overall Survival (OS) - Final Analysis

Description

Time Frame

From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Title

Minimal Residual Disease (MRD) Negativity Rate - Primary Analysis

Description

The MRD negativity rate is defined as the percentage of participants who had MRD negative status with less than one CLL cell per 10,000 leukocytes (< 10-⁴) in peripheral blood and bone marrow. MRD was evaluated using next-generation sequencing. Per protocol, peripheral blood MRD assessments were to be collected from all participants at Week 24 and Week 48 and at the time the bone marrow assessment for confirmation of CR/CRi, and bone marrow (BM) MRD assessments were to be collected for participants undergoing a bone marrow procedure for confirmation of CR/CRi. Participants with no blood or BM MRD assessments were included in the calculation of MRD negativity rate as not having MRD negative status.

Time Frame

From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Title

Minimal Residual Disease (MRD) Negativity Rate - Final Analysis

Description

Time Frame

From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant has Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2 Participant has relapsed/refractory disease (received at least 1 prior therapy) Participant has diagnosis of CLL that meets published 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group (IWCLL NCI-WG) Guidelines and: has an indication for treatment according to the 2008 Modified IWCLL NCI-WG criteria has clinically measurable disease (lymphocytosis greater than 5 × 10^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam) In addition, participants: with or without 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or peripheral blood are eligible may have been previously treated with a prior B-cell receptor inhibitor Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory at Screening Exclusion Criteria: Participant has developed Richter's transformation or Prolymphocytic leukemia Participant has previously received venetoclax History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of: adequately treated in situ carcinoma of the cervix uteri adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin previous malignancy confined and surgically resected (or treated with other modalities) with curative intent Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura despite low dose corticosteroids Participant has undergone an allogeneic stem cell transplant Treatment with any of the following within five half-lives or 14 days (if half-life unknown) as applicable prior to the first dose of venetoclax, or clinically significant adverse effect(s)/toxicity(s) of the previous therapy have not resolved to < National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 Grade 2: Any anti-cancer therapy including chemotherapy, or radiotherapy; Investigational therapy, including targeted small molecule agents Participant is human immunodeficiency virus (HIV) positive Participant has known allergy to both xanthine oxidase inhibitors and rasburicase

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Norton Cancer Institute /ID# 149788

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202-3700

Country

United States

Facility Name

St. Agnes Cancer Center /ID# 149782

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Hackensack Univ Med Ctr /ID# 151574

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Utah Cancer Specialists /ID# 151604

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Cancer Care Northwest /ID# 151605

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

West Virginia Univ School Med /ID# 151602

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

LKH-Univ. Klinikum Graz /ID# 147547

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

LKH Salzburg and Paracelsus /ID# 147549

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Hanusch Krankenhaus der WGKK /ID# 147548

City

Wien

ZIP/Postal Code

1140

Country

Austria

Facility Name

Cliniques Universitaires Saint Luc /ID# 147388

City

Woluwe-Saint-Lambert

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZ Leuven /ID# 147387

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

BC Cancer Agency /ID# 153091

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1L3

Country

Canada

Facility Name

Qe Ii Hsc /Id# 147460

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Juravinski Cancer Clinic /ID# 149152

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 1C3

Country

Canada

Facility Name

Sunnybrook Health Sciences Ctr /ID# 147462

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

CHU de Quebec-Universite Laval /ID# 150299

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Herlev Hospital /ID# 150183

City

Herlev

State/Province

Hovedstaden

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Aarhus University Hospital /ID# 147409

City

Aarhus N

State/Province

Midtjylland

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Turku University Hospital /ID# 147551

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

CHU Dupuytren /ID# 147552

City

Limoges CEDEX 1

State/Province

Franche-Comte

ZIP/Postal Code

87042

Country

France

Facility Name

CHU de la miletrie /ID# 147484

City

Poitiers

State/Province

Poitou-Charentes

ZIP/Postal Code

86021

Country

France

Facility Name

Institut Bergonie /ID# 147482

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

CHRU de Brest - Hopital Morvan /ID# 147485

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

clinique Sainte Anne /ID# 147556

City

Strasbourg

ZIP/Postal Code

67085

Country

France

Facility Name

Onkologische Schwerpunktpraxis /ID# 147516

City

Berlin

ZIP/Postal Code

10707

Country

Germany

Facility Name

Cent fuer Haematologie und Onk /ID# 147511

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

OncoResearch Lerchenfeld GmbH /ID# 164044

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Mannheimer Onkologiepraxis /ID# 147512

City

Mannheim

ZIP/Postal Code

68161

Country

Germany

Facility Name

Staedt. Klinikum Schwabing /ID# 147510

City

Munich

ZIP/Postal Code

80804

Country

Germany

Facility Name

General Hospital of Athens Laiko /ID# 147517

City

Athens

State/Province

Attiki

ZIP/Postal Code

115 27

Country

Greece

Facility Name

G. Papanikolaou Hospital /ID# 147518

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

St. James's Hospital /ID# 147519

City

Dublin 8

State/Province

Dublin

ZIP/Postal Code

D08 E9P6

Country

Ireland

Facility Name

Beaumont Hospital /ID# 147522

City

Dublin

ZIP/Postal Code

D09 XR63

Country

Ireland

Facility Name

Tel Aviv Sourasky Medical Ctr /ID# 151624

City

Tel Aviv-Yafo

State/Province

Tel-Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Galilee Medical Center /ID# 159971

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

Sheba Medical Center /ID# 147509

City

Ramat Gan

ZIP/Postal Code

5262100

Country

Israel

Facility Name

A.O.U. Policlinico S.Orsola-Malpighi /ID# 147505

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

Facility Name

AP Romano Umberto I /ID# 147500

City

Rome

State/Province

Lazio

ZIP/Postal Code

00161

Country

Italy

Facility Name

ASST Grande Ospedale Metropolitano Niguarda /ID# 147503

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20162

Country

Italy

Facility Name

Ospedale San Raffaele IRCCS /ID# 147504

City

Milan

ZIP/Postal Code

20132

Country

Italy

Facility Name

AO Maggiore della Carita /ID# 147499

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Academisch Medisch Centrum /ID# 147494

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Albert Schweitzer Ziekenhuis /ID# 147495

City

Dordrecht

State/Province

Zuid-Holland

ZIP/Postal Code

3318 AT

Country

Netherlands

Facility Name

Haukeland University Hospital /ID# 147382

City

Bergen

State/Province

Hordaland

ZIP/Postal Code

5021

Country

Norway

Facility Name

Rikshospitalet OUS HF /ID# 201812

City

Oslo

ZIP/Postal Code

0450

Country

Norway

Facility Name

IPO Lisboa FG, EPE /ID# 147385

City

Lisboa

ZIP/Postal Code

1099-023

Country

Portugal

Facility Name

IPO Porto FG, EPE /ID# 147389

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Puerto Rico Hematology Oncolog /ID# 150003

City

San Juan

ZIP/Postal Code

00959

Country

Puerto Rico

Facility Name

Hospital Santa Creu i Sant Pau /ID# 151230

City

Barcelona

ZIP/Postal Code

08026

Country

Spain

Facility Name

Fundacion Jimenez Diaz /ID# 151231

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hosp Univ Puerta de Hierro /ID# 147391

City

Majadahonda

ZIP/Postal Code

28222

Country

Spain

Facility Name

Hospital Clinico Univ de Salamanca /ID# 147392

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Hosp Clin Univ de Valencia /ID# 147396

City

València

ZIP/Postal Code

46010

Country

Spain

Facility Name

Skanes Universitetssjukhus Lund /ID# 147439

City

Lund

State/Province

Skane Lan

ZIP/Postal Code

222 41

Country

Sweden

Facility Name

Akademiska Sjukhuset /ID# 150184

City

Uppsala

State/Province

Uppsala Lan

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Hopitaux Universitaires de Geneve /ID# 147930

City

Genève

State/Province

Geneve

ZIP/Postal Code

1205

Country

Switzerland

Facility Name

University Hospital Zurich /ID# 157910

City

Zurich

State/Province

Zuerich

ZIP/Postal Code

8006

Country

Switzerland

Facility Name

Ospedale Regional Bellinzona e /ID# 151232

City

Bellinzona

ZIP/Postal Code

6501

Country

Switzerland

Facility Name

Ankara Univ Medical Faculty /ID# 147443

City

Ankara

ZIP/Postal Code

6100

Country

Turkey

Facility Name

Istanbul University Istanbul Medical Faculty /ID# 156040

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Vehbi Koc vakfi Amerikan Hasta /ID# 147325

City

Istanbul

ZIP/Postal Code

34365

Country

Turkey

Facility Name

Dokuz Eylul University /ID# 147442

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Ondokuz mayis University Facul /ID# 147326

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Blackpool Teaching Hosp NHS /ID# 149581

City

Blackpool

ZIP/Postal Code

FY3 8NR

Country

United Kingdom

Facility Name

Univ Hosp Bristol NHS Foundati /ID# 147647

City

Bristol

ZIP/Postal Code

BS2 8EG

Country

United Kingdom

Facility Name

Southampton General Hospital /ID# 147646

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

The Royal Wolverhampton NHS Tr /ID# 147945

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://vivli.org/ourmember/abbvie/

Learn more about this trial

A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)

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A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) (VENICE I)

Chronic Lymphocytic Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial