Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

A Study to Evaluate the Efficacy of Venetoclax in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Including Those With 17p Deletion or TP53 Mutation or Those Who Have Received a Prior B-cell Receptor Inhibitor. (VENICE I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02756611
Recruitment Status : Active, not recruiting
First Posted : April 29, 2016
Last Update Posted : December 11, 2019
Information provided by (Responsible Party):

Brief Summary:
The purpose of this open-label, single-arm study is to evaluate the efficacy of venetoclax monotherapy in approximately 250 participants with relapsed/refractory CLL including those with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received prior treatment with a B-cell receptor inhibitor. The starting dose of venetoclax is 20 mg once daily. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the treatment period, participants may continue on into a 2-year follow-up period.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Venetoclax Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 22, 2016
Estimated Primary Completion Date : April 3, 2022
Estimated Study Completion Date : April 3, 2022

Arm Intervention/treatment
Experimental: Venetoclax
Venetoclax will be administered orally 20 mg once daily (QD) beginning with a dose-titration phase, and then escalated up to 400 mg QD.
Drug: Venetoclax
Other Name: ABT-199

Primary Outcome Measures :
  1. Complete Remission Rate (CR + CRi) as assessed by the investigator [ Time Frame: When all participants have completed Week 48 disease assessment, or after all enrolled participants have discontinued venetoclax, whichever is earlier. ]
    The proportion of participants achieving a CR or CRi as their best response (per the investigator assessment) based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria.

Secondary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    TTP is defined as the number of days from the date of first dose or enrollment if not dosed to the date of earliest disease progression.

  2. Overall Response Rate (ORR) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    ORR assessed as the proportion of participants with an overall response (CR + CRi + Nodular Partial Remission [nPR] + Partial Remission [PR]) based on the IWCLL NCI-WG criteria.

  3. Duration of Overall Response (DoR) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    DoR is defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the earliest recurrence or progressive disease.

  4. CR Rate (CR + CRi) [ Time Frame: When all participants have completed Week 48 disease assessment, or after all enrolled participants have discontinued venetoclax, whichever is earlier. ]
    CR + CRi in previously treated B-Cell receptor inhibitor (BCRi) subjects assessed based on the 2008 Modified IWCLL NCI-WG criteria.

  5. Overall Survival (OS) [ Time Frame: Measured up to 2 years after the last subject has enrolled into the study. ]
    OS is defined as number of days from the date of first dose to the date of death for all dosed subjects.

  6. Progression-Free Survival (PFS) [ Time Frame: Measured up to 2 years after the last subject has enrolled into the study. ]
    PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.

  7. Rate of Minimal Residual Disease (MRD) [ Time Frame: When all participants have completed Week 48 disease assessment, or after all enrolled participants have discontinued venetoclax, whichever is earlier. ]
    The rate is defined as the proportion of participants who had MRD negativity status.

Other Outcome Measures:
  1. Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) [ Time Frame: Up to Week 108 ]
    The FACT-Leu is a 44-item, leukemia-specific questionnaire designed to assess patient health-related quality of life (HRQoL) and leukemia-specific symptoms.

  2. Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) [ Time Frame: Up to Week 108 ]
    The FACIT-F questionnaire measures fatigue and its effect on functioning and daily activities. The FACIT-F has 13 items answered on a 5-point rating scale based on a 7-day recall period.

  3. EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) [ Time Frame: Up to Week 108 ]
    Five items in the EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) are rated on 5 levels of severity.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 × 109/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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02756611

Hide Hide 67 study locations
Layout table for location information
United States, Kentucky
Norton Cancer Institute /ID# 149788
Louisville, Kentucky, United States, 40202-3700
United States, Maryland
St. Agnes Cancer Center /ID# 149782
Baltimore, Maryland, United States, 21229
United States, New Jersey
Hackensack Univ Med Ctr /ID# 151574
Hackensack, New Jersey, United States, 07601
United States, Utah
Utah Cancer Specialists /ID# 151604
Salt Lake City, Utah, United States, 84106
United States, Washington
Cancer Care Northwest /ID# 151605
Spokane, Washington, United States, 99202
United States, West Virginia
West Virginia Univ School Med /ID# 151602
Morgantown, West Virginia, United States, 26506
LKH-Univ. Klinikum Graz /ID# 147547
Graz, Austria, 8036
LKH Salzburg and Paracelsus /ID# 147549
Salzburg, Austria, 5020
Hanusch Krankenhaus der WGKK /ID# 147548
Wien, Austria, 1140
Cliniques Universitaires Saint Luc /ID# 147388
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
UZ Leuven /ID# 147387
Leuven, Belgium, 3000
Canada, British Columbia
BC Cancer Agency /ID# 153091
Vancouver, British Columbia, Canada, V5Z 1L3
Canada, Nova Scotia
Qe Ii Hsc /Id# 147460
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Clinic /ID# 149152
Hamilton, Ontario, Canada, L8V 1C3
Sunnybrook Health Sciences Ctr /ID# 147462
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CHU de Quebec-Universite Laval /ID# 150299
Quebec City, Quebec, Canada, G1R 2J6
Herlev Hospital /ID# 150183
Herlev, Hovedstaden, Denmark, 2730
Aarhus University Hospital /ID# 147409
Aarhus N, Midtjylland, Denmark, 8200
Turku University Hospital /ID# 147551
Turku, Finland, 20520
CHU Dupuytren /ID# 147552
Limoges CEDEX 1, Franche-Comte, France, 87042
CHU de la miletrie /ID# 147484
Poitiers, Poitou-Charentes, France, 86021
Institut Bergonie /ID# 147482
Bordeaux, France, 33076
CHRU de Brest - Hopital Morvan /ID# 147485
Brest, France, 29200
clinique Sainte Anne /ID# 147556
Strasbourg, France, 67085
Onkologische Schwerpunktpraxis /ID# 147516
Berlin, Germany, 10707
Cent fuer Haematologie und Onk /ID# 147511
Frankfurt, Germany, 60389
OncoResearch Lerchenfeld GmbH /ID# 164044
Hamburg, Germany, 22081
Mannheimer Onkologiepraxis /ID# 147512
Mannheim, Germany, 68161
Staedt. Klinikum Schwabing /ID# 147510
Munich, Germany, 80804
General Hospital of Athens Laiko /ID# 147517
Athens, Attiki, Greece, 115 27
G. Papanikolaou Hospital /ID# 147518
Thessaloniki, Greece, 57010
St. James's Hospital /ID# 147519
Dublin 8, Dublin, Ireland, D08 E9P6
Beaumont Hospital /ID# 147522
Dublin, Ireland, D09 XR63
Tel Aviv Sourasky Medical Ctr /ID# 151624
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Galilee Medical Center /ID# 159971
Nahariya, Israel, 22100
Sheba Medical Center /ID# 147509
Ramat Gan, Israel, 5262100
A.O.U. Policlinico S.Orsola-Malpighi /ID# 147505
Bologna, Emilia-Romagna, Italy, 40138
AP Romano Umberto I /ID# 147500
Rome, Lazio, Italy, 00161
ASST Grande Ospedale Metropolitano Niguarda /ID# 147503
Milano, Lombardia, Italy, 20162
Ospedale San Raffaele IRCCS /ID# 147504
Milan, Italy, 20132
AO Maggiore della Carita /ID# 147499
Novara, Italy, 28100
Academisch Medisch Centrum /ID# 147494
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Albert Schweitzer Ziekenhuis /ID# 147495
Dordrecht, Zuid-Holland, Netherlands, 3318 AT
Haukeland University Hospital /ID# 147382
Bergen, Hordaland, Norway, 5021
Rikshospitalet OUS HF /ID# 201812
Oslo, Norway, 0450
IPO Lisboa FG, EPE /ID# 147385
Lisboa, Portugal, 1099-023
IPO Porto FG, EPE /ID# 147389
Porto, Portugal, 4200-072
Puerto Rico
Puerto Rico Hematology Oncolog /ID# 150003
San Juan, Puerto Rico, 00959
Hospital Santa Creu i Sant Pau /ID# 151230
Barcelona, Spain, 08026
Fundacion Jimenez Diaz /ID# 151231
Madrid, Spain, 28040
Hosp Univ Puerta de Hierro /ID# 147391
Majadahonda, Spain, 28222
Hospital Clinico Univ de Salamanca /ID# 147392
Salamanca, Spain, 37007
Hosp Clin Univ de Valencia /ID# 147396
Valencia, Spain, 46010
Skanes Universitetssjukhus Lund /ID# 147439
Lund, Skane Lan, Sweden, 222 41
Akademiska Sjukhuset /ID# 150184
Uppsala, Uppsala Lan, Sweden, 751 85
Hopitaux Universitaires de Geneve /ID# 147930
Genève, Geneve, Switzerland, 1205
University Hospital Zurich /ID# 157910
Zurich, Zuerich, Switzerland, 8006
Ospedale Regional Bellinzona e /ID# 151232
Bellinzona, Switzerland, 6501
Ankara Univ Medical Faculty /ID# 147443
Ankara, Turkey, 6100
Istanbul University Istanbul Medical Faculty /ID# 156040
Istanbul, Turkey, 34093
Vehbi Koc vakfi Amerikan Hasta /ID# 147325
Istanbul, Turkey, 34365
Dokuz Eylul University /ID# 147442
Izmir, Turkey, 35340
Ondokuz mayis University Facul /ID# 147326
Samsun, Turkey, 55139
United Kingdom
Blackpool Teaching Hosp NHS /ID# 149581
Blackpool, United Kingdom, FY3 8NR
Univ Hosp Bristol NHS Foundati /ID# 147647
Bristol, United Kingdom, BS2 8EG
Southampton General Hospital /ID# 147646
Southampton, United Kingdom, SO16 6YD
The Royal Wolverhampton NHS Tr /ID# 147945
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Layout table for additonal information
Responsible Party: AbbVie Identifier: NCT02756611    
Other Study ID Numbers: M15-550
2015-003667-11 ( EudraCT Number )
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Chronic Lymphocytic Leukemia
17p Deletion
TP53 Mutation
B-Cell receptor inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents