Phase
Condition
Platelet Disorders
Lymphocytic Leukemia, Chronic
Leukemia
Treatment
N/AClinical Study ID
Ages 18-99 All Genders
Study Summary
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
Study Description
Connect with a study center
LKH-Univ. Klinikum Graz /ID# 147547
Graz, 8036
AustriaSite Not Available
LKH Salzburg and Paracelsus /ID# 147549
Salzburg, 5020
AustriaSite Not Available
Hanusch Hospital /ID# 147548
Vienna, 1140
AustriaSite Not Available
Hanusch Krankenhaus der WGKK /ID# 147548
Wien, 1140
AustriaSite Not Available
Cliniques Universitaires Saint Luc /ID# 147388
Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc /ID# 147388
Brussels, 1200
BelgiumSite Not Available
UZ Leuven /ID# 147387
Leuven, 3000
BelgiumSite Not Available
BC Cancer Agency /ID# 153091
Vancouver, British Columbia V5Z 1L3
CanadaSite Not Available
Qe Ii Hsc /Id# 147460
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
Juravinski Cancer Clinic /ID# 149152
Hamilton, Ontario L8V 1C3
CanadaSite Not Available
Sunnybrook Health Sciences Ctr /ID# 147462
Toronto, Ontario M4N 3M5
CanadaSite Not Available
CHU de Quebec-Universite Laval /ID# 150299
Quebec City, Quebec G1R 2J6
CanadaSite Not Available
Queen Elizabeth II Health Sciences Center /ID# 147460
Hailfax, B3H 2Y9
CanadaSite Not Available
CHU de Quebec-Universite Laval /ID# 150299
Quebec, GIJ 1Z4
CanadaSite Not Available
Herlev Hospital /ID# 150183
Herlev, Hovedstaden 2730
DenmarkSite Not Available
Aarhus University Hospital /ID# 147409
Aarhus C, Midtjylland 8000
DenmarkSite Not Available
Aarhus University Hospital /ID# 147409
Aarhus N, Midtjylland 8200
DenmarkSite Not Available
Aarhus University Hospital /ID# 147409
Aarhus, Jylland, 8000
DenmarkSite Not Available
Site Reference ID/Investigator# 147409
Aarhus, Midtjylland, 8000
DenmarkSite Not Available
Turku University Hospital /ID# 147551
Turku, 20520
FinlandSite Not Available
CHU Dupuytren /ID# 147552
Limoges CEDEX 1, Franche-Comte 87042
FranceSite Not Available
CHU de la miletrie /ID# 147484
Poitiers, Poitou-Charentes 86021
FranceSite Not Available
CHRU de Brest - Hopital Morvan /ID# 147485
BREST Cedex, 29609
FranceSite Not Available
Institut Bergonie /ID# 147482
Bordeaux, 33076
FranceSite Not Available
Institut Bergonie /ID# 147482
Bordeaux, Cedex, 33076
FranceSite Not Available
CHRU de Brest - Hopital Morvan /ID# 147485
Brest, 29200
FranceSite Not Available
CHU Dupuytren /ID# 147552
Limoges, 87042
FranceSite Not Available
CHU de la miletrie, Centre d'investigation clinique /ID# 147484
Poitiers Cedex, 86021
FranceSite Not Available
clinique Sainte Anne /ID# 147556
Strasbourg, 67085
FranceSite Not Available
Onkologische Schwerpunktpraxis /ID# 147516
Berlin, 10707
GermanySite Not Available
Cent fuer Haematologie und Onk /ID# 147511
Frankfurt, 60389
GermanySite Not Available
Centrum fuer Haematologie und Onkologie /ID# 147511
Frankfurt am Main, 60389
GermanySite Not Available
Medizinische Universitaetsklin
Freiburg, 79106
GermanySite Not Available
OncoResearch Lerchenfeld GmbH /ID# 164044
Hamburg, 22081
GermanySite Not Available
Mannheimer Onkologiepraxis /ID# 147512
Mannheim, 68161
GermanySite Not Available
Staedt. Klinikum Schwabing /ID# 147510
Munich, 80804
GermanySite Not Available
General Hospital of Athens Laiko /ID# 147517
Athens, Attiki 115 27
GreeceSite Not Available
G. Papanikolaou Hospital /ID# 147518
Thessaloniki, 57010
GreeceSite Not Available
St. James's Hospital /ID# 147519
Dublin 8, Dublin D08 E9P6
IrelandSite Not Available
Beaumont Hospital /ID# 147522
Dublin, D09 XR63
IrelandSite Not Available
Tel Aviv Sourasky Medical Ctr /ID# 151624
Tel Aviv-Yafo, Tel-Aviv 6423906
IsraelSite Not Available
Galilee Medical Center /ID# 159971
Nahariya, 22100
IsraelSite Not Available
Sheba Medical Center /ID# 147509
Ramat Gan, 5262100
IsraelSite Not Available
Tel Aviv Medical Center /ID# 151624
Tel Aviv, 6423906
IsraelSite Not Available
A.O.U. Policlinico S.Orsola-Malpighi /ID# 147505
Bologna, Emilia-Romagna 40138
ItalySite Not Available
AP Romano Umberto I /ID# 147500
Rome, Lazio 00161
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda /ID# 147503
Milano, Lombardia 20162
ItalySite Not Available
Ospedale San Raffaele IRCCS /ID# 147504
Milan, 20132
ItalySite Not Available
AO Maggiore della Carita /ID# 147499
Novara, 28100
ItalySite Not Available
Academisch Medisch Centrum /ID# 147494
Amsterdam, Noord-Holland 1105 AZ
NetherlandsSite Not Available
Albert Schweitzer Ziekenhuis /ID# 147495
Dordrecht, Zuid-Holland 3318 AT
NetherlandsSite Not Available
Haukeland University Hospital /ID# 147382
Bergen, Hordaland 5021
NorwaySite Not Available
Rikshospitalet OUS HF /ID# 201812
Oslo, 0450
NorwaySite Not Available
IPO Lisboa FG, EPE /ID# 147385
Lisboa, 1099-023
PortugalSite Not Available
Instituto Portugues de Oncologia Lisboa Francisco Gentil EPE /ID# 147385
Lisbon, 1099-023
PortugalSite Not Available
IPO Porto FG, EPE /ID# 147389
Porto, 4200-072
PortugalSite Not Available
Puerto Rico Hematology Oncology Group, Inc. /ID# 152363
Bayamon, 00961
Puerto RicoSite Not Available
Puerto Rico Hematology Oncolog /ID# 150003
San Juan, 00959
Puerto RicoSite Not Available
Hospital Santa Creu i Sant Pau /ID# 151230
Barcelona, 08026
SpainSite Not Available
Fundacion Jimenez Diaz /ID# 151231
Madrid, 28040
SpainSite Not Available
Hosp Univ Puerta de Hierro /ID# 147391
Majadahonda, 28222
SpainSite Not Available
Hospital Universitario Puerta de Hierro Majadahonda /ID# 147391
Majadahonda (Madrid), Espana, 28222
SpainSite Not Available
Hospital Clinico Univ de Salamanca /ID# 147392
Salamanca, 37007
SpainSite Not Available
Hospital Universitario de Salamanca /ID# 147392
Salamanca-Espana, 37007
SpainSite Not Available
Hosp Clin Univ de Valencia /ID# 147396
Valencia, 46010
SpainSite Not Available
Hospital Clinico Universitario de Valencia /ID# 147396
Valencia-Espana, 46010
SpainSite Not Available
Hosp Clin Univ de Valencia /ID# 147396
València, 46010
SpainSite Not Available
Skanes Universitetssjukhus Lund /ID# 147439
Lund, Skane Lan 222 41
SwedenSite Not Available
Akademiska Sjukhuset /ID# 150184
Uppsala, Uppsala Lan 751 85
SwedenSite Not Available
Hopitaux Universitaires de Geneve /ID# 147930
Genève, Geneve 1205
SwitzerlandSite Not Available
University Hospital Zurich /ID# 157910
Zurich, Zuerich 8006
SwitzerlandSite Not Available
Ospedale Regional Bellinzona e /ID# 151232
Bellinzona, 6501
SwitzerlandSite Not Available
Hopitaux Universitaires de Geneva /ID# 147930
Geneva 14, 1211
SwitzerlandSite Not Available
Ankara Univ Medical Faculty /ID# 147443
Ankara, 6100
TurkeySite Not Available
Dokuz Eylul University /ID# 147442
Balcova, Izmir, 35340
TurkeySite Not Available
Istanbul University Istanbul Medical Faculty /ID# 156040
Istanbul, 34093
TurkeySite Not Available
Vehbi Koc vakfi Amerikan Hasta /ID# 147325
Istanbul, 34365
TurkeySite Not Available
Dokuz Eylul University /ID# 147442
Izmir, 35340
TurkeySite Not Available
Ondokuz Mayis University /ID# 147326
Kurupelit, Samsun, 55139
TurkeySite Not Available
Ondokuz mayis University Facul /ID# 147326
Samsun, 55139
TurkeySite Not Available
Blackpool Teaching Hosp NHS /ID# 149581
Blackpool, FY3 8NR
United KingdomSite Not Available
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 149581
Blackpool, Lancashire, FY3 8NR
United KingdomSite Not Available
Univ Hosp Bristol NHS Foundati /ID# 147647
Bristol, BS2 8EG
United KingdomSite Not Available
Southampton General Hospital /ID# 147646
Southampton, SO16 6YD
United KingdomSite Not Available
The Royal Wolverhampton NHS Tr /ID# 147945
Wolverhampton, WV10 0QP
United KingdomSite Not Available
The Royal Wolverhampton NHS Trust /ID# 147945
Wolverhampton, West Midlands, WV10 0QP
United KingdomSite Not Available
Norton Cancer Institute /ID# 149788
Louisiville, Kentucky 40207
United StatesSite Not Available
Norton Cancer Institute /ID# 149788
Louisville, Kentucky 40202-3700
United StatesSite Not Available
St. Agnes Cancer Center /ID# 149782
Baltimore, Maryland 21229
United StatesSite Not Available
Hackensack Univ Med Ctr /ID# 151574
Hackensack, New Jersey 07601
United StatesSite Not Available
Utah Cancer Specialists /ID# 151604
Salt Lake City, Utah 84106
United StatesSite Not Available
Cancer Care Northwest /ID# 151605
Spokane, Washington 99202
United StatesSite Not Available
Cancer Care Northwest /ID# 151605
Spokane Valley, Washington 99216
United StatesSite Not Available
West Virginia Univ School Med /ID# 151602
Morgantown, West Virginia 26506
United StatesSite Not Available

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