An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

Cancer Clinical Trial

Official title:

An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03844048
• Other study ID #: M19-388
• Secondary ID: 2022-501522-38-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 6, 2019
• Est. completion date: May 27, 2025

Study information

• Verified date: December 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: May 27, 2025
• Est. primary completion date: May 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Cancer
• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Non-Hodgkin's Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Venetoclax
oral; film-coated tablets or tablets for oral suspension

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  France,  Greece,  Hong Kong,  Ireland,  Japan,  Korea, Republic of,  Mexico,  New Zealand,  Poland,  Portugal,  Russian Federation,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.	From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).

External Links

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