Clinical trial NCT03844048: An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
Official title: An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Acute Myeloid Leukemia
Multiple Myeloma
Non-Hodgkin's Lymphoma
Acute Lymphoblastic Leukemia
Cancer
Keywords: Chronic Lymphocytic Leukemia (CLL)
Acute Myeloid Leukemia (AML)
Multiple Myeloma (MM)
Non-Hodgkin's Lymphoma (NHL)
Acute Lymphoblastic Leukemia (ALL)
Cancer
Venetoclax
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-02-18
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.


Eligibility criteria: Inclusion Criteria:

* Subject has been enrolled and dosed in an ongoing venetoclax study and continues to tolerate and derive benefit from the study drug.
* Male subject agrees to refrain from sperm donation.
* Female subjects must not be pregnant or breastfeeding.

Exclusion Criteria:

- None.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center - Tucson /ID# 210548
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Santa Monica Hematology Oncology /ID# 210551
state: California
city: Harvey
country: United States
facility: Ingalls Memorial Hosp /ID# 210553
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 215360
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 210555
state: New Hampshire
city: Seattle
country: United States
facility: Swedish Cancer Institute /ID# 213120
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital /ID# 239557
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital /ID# 225589
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital /ID# 225591
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Ctr /ID# 210559
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital /ID# 239480
state: Western Australia
city: Nedlands
country: Australia
facility: Perth Blood Institute Ltd /ID# 225592
state: Western Australia
city: Graz
country: Austria
facility: Duplicate_Medizinische Universitaet Graz /ID# 223817
state: Steiermark
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 224327
state: Bruxelles-Capitale
city: Quebec City
country: Canada
facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616
state: Quebec
city: Copenhagen Ø
country: Denmark
facility: Rigshospitalet /ID# 224213
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital - Skejby /ID# 224214
state: Midtjylland
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 240497
state: Isere
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 213508
state: Rhone
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 224087
state: Attiki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki George Papanikolaou /ID# 224088
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital /ID# 224944
city: Dublin
country: Ireland
facility: Beaumont Hospital /ID# 225165
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 241518
state: Hyogo
city: Higashi Ibaraki-gun
country: Japan
facility: Duplicate_National Hospital Organization Mito Medical Center /ID# 241986
state: Ibaraki
city: Okayama-shi
country: Japan
facility: Okayama Medical Center /ID# 241517
state: Okayama
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 241516
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 240882
state: Seoul Teugbyeolsi
city: Morelia
country: Mexico
facility: Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018
state: Michoacan
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017
state: Nuevo Leon
city: Papatoetoe
country: New Zealand
facility: Aotearoa Clinical Trials /ID# 225596
state: Auckland
city: Takapuna
country: New Zealand
facility: North Shore Hospital /ID# 225597
state: Auckland
city: Newtown
country: New Zealand
facility: Wellington Regional Hospital /ID# 225593
state: Wellington
city: Krakow
country: Poland
facility: Duplicate_Pratia MCM Krakow /ID# 218561
state: Malopolskie
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii /ID# 225478
state: Mazowieckie
city: Chorzow
country: Poland
facility: SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474
state: Slaskie
city: Lisboa
country: Portugal
facility: IPO Lisboa FG, EPE /ID# 225072
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194
state: Moskva
city: Penza
country: Russian Federation
facility: Regional Oncological Dispensary /ID# 225195
state: Penzenskaya Oblast
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 225476
city: Lund
country: Sweden
facility: Duplicate_Skane University Hospital Lund /ID# 224747
state: Skane Lan
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 224946
state: Taipei
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 224945
city: Ankara
country: Turkey
facility: Ankara Univ Medical Faculty /ID# 225043
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty /ID# 225045
city: Istanbul
country: Turkey
facility: Vehbi Koc vakfi Amerikan Hasta /ID# 225046
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 240575
city: Plymouth
country: United Kingdom
facility: Derriford Hospital and the Royal Eye Infirmary /ID# 218731
state: Devon
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary /ID# 240468
state: England
city: London
country: United Kingdom
facility: University College London Hospital /ID# 240467
state: Greater London
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust /ID# 225161
state: Hampshire
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163
city: Liverpool
country: United Kingdom
facility: Clatterbridge Cancer Centre - Liverpool /ID# 218736
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 218735
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust /ID# 225164
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: