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

Last updated: April 7, 2023
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Platelet Disorders

Lymphocytic Leukemia, Chronic

Leukemia

Treatment

N/A

Clinical Study ID

NCT02756611
M15-550
2015-003667-11
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has Eastern Cooperative Oncology Group (ECOG) performance score of lessthan 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 InternationalWorkshop 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-WGcriteria
  • has clinically measurable disease (lymphocytosis greater than 5 × 10^9/L and/orpalpable and measurable nodes by physical exam and/or organomegaly assessed byphysical exam)
  • In addition, participants:
  • with or without 17p deletion or TP53 mutation, assessed by a local laboratory inbone 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, andhepatic function, per laboratory at Screening

Exclusion

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 firstdose 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 ofthe skin
  • previous malignancy confined and surgically resected (or treated with othermodalities) with curative intent
  • Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior toScreening), including autoimmune hemolytic anemia and idiopathic thrombocytopenicpurpura 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-lifeunknown) as applicable prior to the first dose of venetoclax, or clinicallysignificant 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

Study Design

Total Participants: 258
Study Start date:
June 22, 2016
Estimated Completion Date:
March 11, 2022

Study 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.

Connect with a study center

  • LKH-Univ. Klinikum Graz /ID# 147547

    Graz, 8036
    Austria

    Site Not Available

  • LKH Salzburg and Paracelsus /ID# 147549

    Salzburg, 5020
    Austria

    Site Not Available

  • Hanusch Hospital /ID# 147548

    Vienna, 1140
    Austria

    Site Not Available

  • Hanusch Krankenhaus der WGKK /ID# 147548

    Wien, 1140
    Austria

    Site Not Available

  • Cliniques Universitaires Saint Luc /ID# 147388

    Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc /ID# 147388

    Brussels, 1200
    Belgium

    Site Not Available

  • UZ Leuven /ID# 147387

    Leuven, 3000
    Belgium

    Site Not Available

  • BC Cancer Agency /ID# 153091

    Vancouver, British Columbia V5Z 1L3
    Canada

    Site Not Available

  • Qe Ii Hsc /Id# 147460

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Juravinski Cancer Clinic /ID# 149152

    Hamilton, Ontario L8V 1C3
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Ctr /ID# 147462

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • CHU de Quebec-Universite Laval /ID# 150299

    Quebec City, Quebec G1R 2J6
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Center /ID# 147460

    Hailfax, B3H 2Y9
    Canada

    Site Not Available

  • CHU de Quebec-Universite Laval /ID# 150299

    Quebec, GIJ 1Z4
    Canada

    Site Not Available

  • Herlev Hospital /ID# 150183

    Herlev, Hovedstaden 2730
    Denmark

    Site Not Available

  • Aarhus University Hospital /ID# 147409

    Aarhus C, Midtjylland 8000
    Denmark

    Site Not Available

  • Aarhus University Hospital /ID# 147409

    Aarhus N, Midtjylland 8200
    Denmark

    Site Not Available

  • Aarhus University Hospital /ID# 147409

    Aarhus, Jylland, 8000
    Denmark

    Site Not Available

  • Site Reference ID/Investigator# 147409

    Aarhus, Midtjylland, 8000
    Denmark

    Site Not Available

  • Turku University Hospital /ID# 147551

    Turku, 20520
    Finland

    Site Not Available

  • CHU Dupuytren /ID# 147552

    Limoges CEDEX 1, Franche-Comte 87042
    France

    Site Not Available

  • CHU de la miletrie /ID# 147484

    Poitiers, Poitou-Charentes 86021
    France

    Site Not Available

  • CHRU de Brest - Hopital Morvan /ID# 147485

    BREST Cedex, 29609
    France

    Site Not Available

  • Institut Bergonie /ID# 147482

    Bordeaux, 33076
    France

    Site Not Available

  • Institut Bergonie /ID# 147482

    Bordeaux, Cedex, 33076
    France

    Site Not Available

  • CHRU de Brest - Hopital Morvan /ID# 147485

    Brest, 29200
    France

    Site Not Available

  • CHU Dupuytren /ID# 147552

    Limoges, 87042
    France

    Site Not Available

  • CHU de la miletrie, Centre d'investigation clinique /ID# 147484

    Poitiers Cedex, 86021
    France

    Site Not Available

  • clinique Sainte Anne /ID# 147556

    Strasbourg, 67085
    France

    Site Not Available

  • Onkologische Schwerpunktpraxis /ID# 147516

    Berlin, 10707
    Germany

    Site Not Available

  • Cent fuer Haematologie und Onk /ID# 147511

    Frankfurt, 60389
    Germany

    Site Not Available

  • Centrum fuer Haematologie und Onkologie /ID# 147511

    Frankfurt am Main, 60389
    Germany

    Site Not Available

  • Medizinische Universitaetsklin

    Freiburg, 79106
    Germany

    Site Not Available

  • OncoResearch Lerchenfeld GmbH /ID# 164044

    Hamburg, 22081
    Germany

    Site Not Available

  • Mannheimer Onkologiepraxis /ID# 147512

    Mannheim, 68161
    Germany

    Site Not Available

  • Staedt. Klinikum Schwabing /ID# 147510

    Munich, 80804
    Germany

    Site Not Available

  • General Hospital of Athens Laiko /ID# 147517

    Athens, Attiki 115 27
    Greece

    Site Not Available

  • G. Papanikolaou Hospital /ID# 147518

    Thessaloniki, 57010
    Greece

    Site Not Available

  • St. James's Hospital /ID# 147519

    Dublin 8, Dublin D08 E9P6
    Ireland

    Site Not Available

  • Beaumont Hospital /ID# 147522

    Dublin, D09 XR63
    Ireland

    Site Not Available

  • Tel Aviv Sourasky Medical Ctr /ID# 151624

    Tel Aviv-Yafo, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Galilee Medical Center /ID# 159971

    Nahariya, 22100
    Israel

    Site Not Available

  • Sheba Medical Center /ID# 147509

    Ramat Gan, 5262100
    Israel

    Site Not Available

  • Tel Aviv Medical Center /ID# 151624

    Tel Aviv, 6423906
    Israel

    Site Not Available

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

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • AP Romano Umberto I /ID# 147500

    Rome, Lazio 00161
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 147503

    Milano, Lombardia 20162
    Italy

    Site Not Available

  • Ospedale San Raffaele IRCCS /ID# 147504

    Milan, 20132
    Italy

    Site Not Available

  • AO Maggiore della Carita /ID# 147499

    Novara, 28100
    Italy

    Site Not Available

  • Academisch Medisch Centrum /ID# 147494

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis /ID# 147495

    Dordrecht, Zuid-Holland 3318 AT
    Netherlands

    Site Not Available

  • Haukeland University Hospital /ID# 147382

    Bergen, Hordaland 5021
    Norway

    Site Not Available

  • Rikshospitalet OUS HF /ID# 201812

    Oslo, 0450
    Norway

    Site Not Available

  • IPO Lisboa FG, EPE /ID# 147385

    Lisboa, 1099-023
    Portugal

    Site Not Available

  • Instituto Portugues de Oncologia Lisboa Francisco Gentil EPE /ID# 147385

    Lisbon, 1099-023
    Portugal

    Site Not Available

  • IPO Porto FG, EPE /ID# 147389

    Porto, 4200-072
    Portugal

    Site Not Available

  • Puerto Rico Hematology Oncology Group, Inc. /ID# 152363

    Bayamon, 00961
    Puerto Rico

    Site Not Available

  • Puerto Rico Hematology Oncolog /ID# 150003

    San Juan, 00959
    Puerto Rico

    Site Not Available

  • Hospital Santa Creu i Sant Pau /ID# 151230

    Barcelona, 08026
    Spain

    Site Not Available

  • Fundacion Jimenez Diaz /ID# 151231

    Madrid, 28040
    Spain

    Site Not Available

  • Hosp Univ Puerta de Hierro /ID# 147391

    Majadahonda, 28222
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda /ID# 147391

    Majadahonda (Madrid), Espana, 28222
    Spain

    Site Not Available

  • Hospital Clinico Univ de Salamanca /ID# 147392

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca /ID# 147392

    Salamanca-Espana, 37007
    Spain

    Site Not Available

  • Hosp Clin Univ de Valencia /ID# 147396

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia /ID# 147396

    Valencia-Espana, 46010
    Spain

    Site Not Available

  • Hosp Clin Univ de Valencia /ID# 147396

    València, 46010
    Spain

    Site Not Available

  • Skanes Universitetssjukhus Lund /ID# 147439

    Lund, Skane Lan 222 41
    Sweden

    Site Not Available

  • Akademiska Sjukhuset /ID# 150184

    Uppsala, Uppsala Lan 751 85
    Sweden

    Site Not Available

  • Hopitaux Universitaires de Geneve /ID# 147930

    Genève, Geneve 1205
    Switzerland

    Site Not Available

  • University Hospital Zurich /ID# 157910

    Zurich, Zuerich 8006
    Switzerland

    Site Not Available

  • Ospedale Regional Bellinzona e /ID# 151232

    Bellinzona, 6501
    Switzerland

    Site Not Available

  • Hopitaux Universitaires de Geneva /ID# 147930

    Geneva 14, 1211
    Switzerland

    Site Not Available

  • Ankara Univ Medical Faculty /ID# 147443

    Ankara, 6100
    Turkey

    Site Not Available

  • Dokuz Eylul University /ID# 147442

    Balcova, Izmir, 35340
    Turkey

    Site Not Available

  • Istanbul University Istanbul Medical Faculty /ID# 156040

    Istanbul, 34093
    Turkey

    Site Not Available

  • Vehbi Koc vakfi Amerikan Hasta /ID# 147325

    Istanbul, 34365
    Turkey

    Site Not Available

  • Dokuz Eylul University /ID# 147442

    Izmir, 35340
    Turkey

    Site Not Available

  • Ondokuz Mayis University /ID# 147326

    Kurupelit, Samsun, 55139
    Turkey

    Site Not Available

  • Ondokuz mayis University Facul /ID# 147326

    Samsun, 55139
    Turkey

    Site Not Available

  • Blackpool Teaching Hosp NHS /ID# 149581

    Blackpool, FY3 8NR
    United Kingdom

    Site Not Available

  • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 149581

    Blackpool, Lancashire, FY3 8NR
    United Kingdom

    Site Not Available

  • Univ Hosp Bristol NHS Foundati /ID# 147647

    Bristol, BS2 8EG
    United Kingdom

    Site Not Available

  • Southampton General Hospital /ID# 147646

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • The Royal Wolverhampton NHS Tr /ID# 147945

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • The Royal Wolverhampton NHS Trust /ID# 147945

    Wolverhampton, West Midlands, WV10 0QP
    United Kingdom

    Site Not Available

  • Norton Cancer Institute /ID# 149788

    Louisiville, Kentucky 40207
    United States

    Site Not Available

  • Norton Cancer Institute /ID# 149788

    Louisville, Kentucky 40202-3700
    United States

    Site Not Available

  • St. Agnes Cancer Center /ID# 149782

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Hackensack Univ Med Ctr /ID# 151574

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Utah Cancer Specialists /ID# 151604

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Cancer Care Northwest /ID# 151605

    Spokane, Washington 99202
    United States

    Site Not Available

  • Cancer Care Northwest /ID# 151605

    Spokane Valley, Washington 99216
    United States

    Site Not Available

  • West Virginia Univ School Med /ID# 151602

    Morgantown, West Virginia 26506
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.