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

Sponsor

AbbVie (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03844048

Collaborator

(none)

550

Enrollment

Locations

Arm

68.6

Anticipated Duration (Months)

10.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Acute Myeloid Leukemia Multiple Myeloma Non-Hodgkin's Lymphoma Acute Lymphoblastic Leukemia Cancer	Drug: Venetoclax	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

550 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 6, 2019

Anticipated Primary Completion Date :

May 26, 2025

Anticipated Study Completion Date :

May 26, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Venetoclax Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.	Drug: Venetoclax oral; film-coated tablets or tablets for oral suspension Other Names: ABT-199 Venclexta

Arm

Intervention/Treatment

Experimental: Venetoclax

Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.

Drug: Venetoclax

oral; film-coated tablets or tablets for oral suspension

Other Names:

ABT-199

Venclexta

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events [From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Cancer Center - Tucson /ID# 210548	Tucson	Arizona	United States	85724
2	UCLA Santa Monica Hematology Oncology /ID# 210551	Los Angeles	California	United States	90095
3	Ingalls Memorial Hosp /ID# 210553	Harvey	Illinois	United States	60426
4	Dana-Farber Cancer Institute /ID# 215360	Boston	Massachusetts	United States	02215
5	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132	Ann Arbor	Michigan	United States	48109
6	Dartmouth-Hitchcock Medical Center /ID# 210555	Lebanon	New Hampshire	United States	03756
7	Duplicate_Gabrail Cancer Center Research /ID# 212061	Canton	Ohio	United States	44718
8	Swedish Cancer Institute - Edmonds /ID# 213120	Seattle	Washington	United States	98104
9	Royal Prince Alfred Hospital /ID# 239557	Camperdown	New South Wales	Australia	2050
10	The Kinghorn Cancer Centre /ID# 241675	Darlinghurst	New South Wales	Australia	2010
11	St George Hospital /ID# 225589	Kogarah	New South Wales	Australia	2217
12	Liverpool Hospital /ID# 225591	Liverpool	New South Wales	Australia	2170
13	Peter MacCallum Cancer Ctr /ID# 210559	Melbourne	Victoria	Australia	3000
14	Fiona Stanley Hospital /ID# 239480	Murdoch	Western Australia	Australia	6150
15	Perth Blood Institute Ltd /ID# 225592	Nedlands	Western Australia	Australia	6009
16	Medizinische Universitaet Graz /ID# 223817	Graz	Steiermark	Austria	8036
17	UCL Saint-Luc /ID# 224327	Woluwe-Saint-Lambert	Bruxelles-Capitale	Belgium	1200
18	CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616	Quebec City	Quebec	Canada	G1J 1Z4
19	Rigshospitalet /ID# 224213	Copenhagen Ø	Hovedstaden	Denmark	2100
20	Aarhus University Hospital /ID# 224214	Aarhus N	Midtjylland	Denmark	8200
21	HCL - Hôpital Lyon Sud /ID# 213508	Pierre Benite CEDEX	Auvergne-Rhone-Alpes	France	69495
22	General Hospital of Athens Laiko /ID# 224087	Athens	Attiki	Greece	11527
23	General Hospital of Thessaloniki George Papanikolaou /ID# 224088	Thessaloniki		Greece	57010
24	Queen Mary Hospital /ID# 224944	Hong Kong		Hong Kong	999077
25	Beaumont Hospital /ID# 225165	Beaumont	Dublin	Ireland	D09 XR63
26	Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018	Morelia	Michoacan	Mexico	58260
27	Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017	Monterrey	Nuevo Leon	Mexico	64460
28	Middlemore Clinical Trials /ID# 225596	Papatoetoe	Auckland	New Zealand	2025
29	North Shore Hospital /ID# 225597	Takapuna	Auckland	New Zealand	0622
30	Wellington Regional Hospital /ID# 225593	Newtown	Wellington	New Zealand	6021
31	Pratia MCM Krakow /ID# 218561	Krakow	Malopolskie	Poland	30-510
32	Instytut Hematologii i Transfuzjologii /ID# 225478	Warszawa	Mazowieckie	Poland	02-776
33	SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474	Chorzow	Slaskie	Poland	41-500
34	IPO Lisboa FG, EPE /ID# 225072	Lisboa		Portugal	1099-023
35	Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194	Moscow	Moskva	Russian Federation	115478
36	Regional Oncological Dispensary /ID# 225195	Penza	Penzenskaya Oblast	Russian Federation	440071
37	Hospital Universitario Fundacion Jimenez Diaz /ID# 225476	Madrid		Spain	28040
38	Skane University Hospital Lund /ID# 224747	Lund	Skane Lan	Sweden	SE 221 41
39	China Medical University Hospital /ID# 224945	Taichung City		Taiwan	40447
40	National Taiwan University Hospital /ID# 224946	Taipei City		Taiwan	100
41	Ankara Univ Medical Faculty /ID# 225043	Ankara		Turkey	06590
42	Istanbul University Istanbul Medical Faculty /ID# 225045	Istanbul		Turkey	34093
43	Vehbi Koc vakfi Amerikan Hasta /ID# 225046	Istanbul		Turkey	34365
44	Dokuz Eylul University Medical Faculty /ID# 225044	Izmir		Turkey	35340
45	Ondokuz mayis University Facul /ID# 225042	Samsun		Turkey	55200
46	University Hospitals Bristol NHS Foundation Trust /ID# 225162	Bristol	Bristol, City Of	United Kingdom	BS1 3NU
47	University Hospital Southampton NHS Foundation Trust /ID# 225161	Southampton	Hampshire	United Kingdom	SO16 6YD
48	Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163	Blackpool		United Kingdom	FY3 8NR
49	The Clatterbridge Cancer Centre NHS Foundation Trust /ID# 218736	Liverpool		United Kingdom	L7 8YA
50	King's College Hospital NHS Foundation Trusts /ID# 218735	London		United Kingdom	SE5 9RS
51	University Hospital Plymouth NHS Trust /ID# 218731	Plymouth		United Kingdom	PL6 5FP
52	The Royal Wolverhampton NHS Trust /ID# 225164	Wolverhampton		United Kingdom	WV10 0QP