Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory leukemia-cll/" >CLL including those with the 17p deletion or TP53 mutation OR those who have received prior treatment with a B-cell receptor inhibitor.

View Eligibility Criteria

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 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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

258

Study ID:

NCT02756611

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 67 Locations for this study

See Locations Near You

Norton Cancer Institute /ID# 149788
Louisville Kentucky, 40202, United States
St. Agnes Cancer Center /ID# 149782
Baltimore Maryland, 21229, United States
Hackensack Univ Med Ctr /ID# 151574
Hackensack New Jersey, 07601, United States
Utah Cancer Specialists /ID# 151604
Salt Lake City Utah, 84106, United States
Cancer Care Northwest /ID# 151605
Spokane Washington, 99202, United States
West Virginia Univ School Med /ID# 151602
Morgantown West Virginia, 26506, United States
LKH-Univ. Klinikum Graz /ID# 147547
Graz , 8036, Austria
LKH Salzburg and Paracelsus /ID# 147549
Salzburg , 5020, Austria
Hanusch Krankenhaus der WGKK /ID# 147548
Wien , 1140, Austria
Cliniques Universitaires Saint Luc /ID# 147388
Woluwe-Saint-Lambert Bruxelles-Capitale, 1200, Belgium
UZ Leuven /ID# 147387
Leuven , 3000, Belgium
BC Cancer Agency /ID# 153091
Vancouver British Columbia, V5Z 1, Canada
Qe Ii Hsc /Id# 147460
Halifax Nova Scotia, B3H 1, Canada
Juravinski Cancer Clinic /ID# 149152
Hamilton Ontario, L8V 1, Canada
Sunnybrook Health Sciences Ctr /ID# 147462
Toronto Ontario, M4N 3, Canada
CHU de Quebec-Universite Laval /ID# 150299
Quebec City Quebec, G1R 2, Canada
Herlev Hospital /ID# 150183
Herlev Hovedstaden, 2730, Denmark
Aarhus University Hospital /ID# 147409
Aarhus N Midtjylland, 8200, Denmark
Turku University Hospital /ID# 147551
Turku , 20520, Finland
CHU Dupuytren /ID# 147552
Limoges CEDEX 1 Franche-Comte, 87042, France
CHU de la miletrie /ID# 147484
Poitiers Poitou-Charentes, 86021, France
Institut Bergonie /ID# 147482
Bordeaux , 33076, France
CHRU de Brest - Hopital Morvan /ID# 147485
Brest , 29200, France
clinique Sainte Anne /ID# 147556
Strasbourg , 67085, France
Onkologische Schwerpunktpraxis /ID# 147516
Berlin , 10707, Germany
Cent fuer Haematologie und Onk /ID# 147511
Frankfurt , 60389, Germany
OncoResearch Lerchenfeld GmbH /ID# 164044
Hamburg , 22081, Germany
Mannheimer Onkologiepraxis /ID# 147512
Mannheim , 68161, Germany
Staedt. Klinikum Schwabing /ID# 147510
Munich , 80804, Germany
General Hospital of Athens Laiko /ID# 147517
Athens Attiki, 115 2, Greece
G. Papanikolaou Hospital /ID# 147518
Thessaloniki , 57010, Greece
St. James's Hospital /ID# 147519
Dublin 8 Dublin, D08 E, Ireland
Beaumont Hospital /ID# 147522
Dublin , D09 X, Ireland
Tel Aviv Sourasky Medical Ctr /ID# 151624
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Galilee Medical Center /ID# 159971
Nahariya , 22100, Israel
Sheba Medical Center /ID# 147509
Ramat Gan , 52621, Israel
A.O.U. Policlinico S.Orsola-Malpighi /ID# 147505
Bologna Emilia-Romagna, 40138, Italy
AP Romano Umberto I /ID# 147500
Rome Lazio, 00161, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 147503
Milano Lombardia, 20162, Italy
Ospedale San Raffaele IRCCS /ID# 147504
Milan , 20132, Italy
AO Maggiore della Carita /ID# 147499
Novara , 28100, Italy
Academisch Medisch Centrum /ID# 147494
Amsterdam Noord-Holland, 1105 , Netherlands
Albert Schweitzer Ziekenhuis /ID# 147495
Dordrecht Zuid-Holland, 3318 , Netherlands
Haukeland University Hospital /ID# 147382
Bergen Hordaland, 5021, Norway
Rikshospitalet OUS HF /ID# 201812
Oslo , 0450, Norway
IPO Lisboa FG, EPE /ID# 147385
Lisboa , 1099-, Portugal
IPO Porto FG, EPE /ID# 147389
Porto , 4200-, Portugal
Puerto Rico Hematology Oncolog /ID# 150003
San Juan , 00959, Puerto Rico
Hospital Santa Creu i Sant Pau /ID# 151230
Barcelona , 08026, Spain
Fundacion Jimenez Diaz /ID# 151231
Madrid , 28040, Spain
Hosp Univ Puerta de Hierro /ID# 147391
Majadahonda , 28222, Spain
Hospital Clinico Univ de Salamanca /ID# 147392
Salamanca , 37007, Spain
Hosp Clin Univ de Valencia /ID# 147396
València , 46010, Spain
Skanes Universitetssjukhus Lund /ID# 147439
Lund Skane Lan, 222 4, Sweden
Akademiska Sjukhuset /ID# 150184
Uppsala Uppsala Lan, 751 8, Sweden
Hopitaux Universitaires de Geneve /ID# 147930
Genève Geneve, 1205, Switzerland
University Hospital Zurich /ID# 157910
Zurich Zuerich, 8006, Switzerland
Ospedale Regional Bellinzona e /ID# 151232
Bellinzona , 6501, Switzerland
Ankara Univ Medical Faculty /ID# 147443
Ankara , 6100, Turkey
Istanbul University Istanbul Medical Faculty /ID# 156040
Istanbul , 34093, Turkey
Vehbi Koc vakfi Amerikan Hasta /ID# 147325
Istanbul , 34365, Turkey
Dokuz Eylul University /ID# 147442
Izmir , 35340, Turkey
Ondokuz mayis University Facul /ID# 147326
Samsun , 55139, Turkey
Blackpool Teaching Hosp NHS /ID# 149581
Blackpool , FY3 8, United Kingdom
Univ Hosp Bristol NHS Foundati /ID# 147647
Bristol , BS2 8, United Kingdom
Southampton General Hospital /ID# 147646
Southampton , SO16 , United Kingdom
The Royal Wolverhampton NHS Tr /ID# 147945
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

258

Study ID:

NCT02756611

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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