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

Primary Purpose

Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia, Multiple Myeloma

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Venetoclax
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), Non-Hodgkin's Lymphoma (NHL), Acute Lymphoblastic Leukemia (ALL), Cancer, Venetoclax

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Arizona Cancer Center - Tucson /ID# 210548
  • UCLA Santa Monica Hematology Oncology /ID# 210551
  • Ingalls Memorial Hosp /ID# 210553
  • Dana-Farber Cancer Institute /ID# 215360
  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132
  • Dartmouth-Hitchcock Medical Center /ID# 210555
  • Gabrail Cancer Center Research /ID# 212061
  • Swedish Cancer Institute - Edmonds /ID# 213120
  • Royal Prince Alfred Hospital /ID# 239557
  • The Kinghorn Cancer Centre /ID# 241675
  • St George Hospital /ID# 225589
  • Liverpool Hospital /ID# 225591
  • Peter MacCallum Cancer Ctr /ID# 210559
  • Fiona Stanley Hospital /ID# 239480
  • Perth Blood Institute Ltd /ID# 225592
  • Medizinische Universitaet Graz /ID# 223817
  • UCL Saint-Luc /ID# 224327
  • CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616
  • Rigshospitalet /ID# 224213
  • Aarhus University Hospital /ID# 224214
  • HCL - Hopital Lyon Sud /ID# 213508
  • CHU Grenoble - Hopital Michallon /ID# 240497
  • General Hospital of Athens Laiko /ID# 224087
  • General Hospital of Thessaloniki George Papanikolaou /ID# 224088
  • Queen Mary Hospital /ID# 224944
  • Beaumont Hospital /ID# 225165
  • Kobe City Medical Center General Hospital /ID# 241518
  • National Hospital Organization Mito Medical Center /ID# 241986
  • Okayama Medical Center /ID# 241517
  • National Cancer Center Hospital /ID# 241516
  • Samsung Medical Center /ID# 240882
  • Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017
  • Middlemore Clinical Trials /ID# 225596
  • North Shore Hospital /ID# 225597
  • Wellington Regional Hospital /ID# 225593
  • Pratia MCM Krakow /ID# 218561
  • Instytut Hematologii i Transfuzjologii /ID# 225478
  • SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474
  • IPO Lisboa FG, EPE /ID# 225072
  • Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194
  • Regional Oncological Dispensary /ID# 225195
  • Hospital Universitario Fundacion Jimenez Diaz /ID# 225476
  • Skane University Hospital Lund /ID# 224747
  • China Medical University Hospital /ID# 224945
  • National Taiwan University Hospital /ID# 224946
  • Ankara Univ Medical Faculty /ID# 225043
  • Istanbul University Istanbul Medical Faculty /ID# 225045
  • Vehbi Koc vakfi Amerikan Hasta /ID# 225046
  • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 240575
  • Leicester Royal Infirmary /ID# 240468
  • University Hospital Southampton NHS Foundation Trust /ID# 225161
  • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163
  • The Clatterbridge Cancer Centre NHS Foundation Trust /ID# 218736
  • University College London Hospitals NHS Foundation Trust /ID# 240467
  • King's College Hospital NHS Foundation Trust /ID# 218735
  • University Hospital Plymouth NHS Trust /ID# 218731
  • The Royal Wolverhampton NHS Trust /ID# 225164

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venetoclax

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2019
Last Updated
February 27, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03844048
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
May 27, 2025 (Anticipated)
Study Completion Date
May 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Venetoclax
Arm Type
Experimental
Arm Description
Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, Venclexta
Intervention Description
oral; film-coated tablets or tablets for oral suspension
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center - Tucson /ID# 210548
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UCLA Santa Monica Hematology Oncology /ID# 210551
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ingalls Memorial Hosp /ID# 210553
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 215360
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 210555
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 212061
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Swedish Cancer Institute - Edmonds /ID# 213120
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Royal Prince Alfred Hospital /ID# 239557
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
The Kinghorn Cancer Centre /ID# 241675
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St George Hospital /ID# 225589
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Liverpool Hospital /ID# 225591
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Peter MacCallum Cancer Ctr /ID# 210559
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Fiona Stanley Hospital /ID# 239480
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Perth Blood Institute Ltd /ID# 225592
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Medizinische Universitaet Graz /ID# 223817
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
UCL Saint-Luc /ID# 224327
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Rigshospitalet /ID# 224213
City
Copenhagen Ø
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Aarhus University Hospital /ID# 224214
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
HCL - Hopital Lyon Sud /ID# 213508
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Grenoble - Hopital Michallon /ID# 240497
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
General Hospital of Athens Laiko /ID# 224087
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Thessaloniki George Papanikolaou /ID# 224088
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Queen Mary Hospital /ID# 224944
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Beaumont Hospital /ID# 225165
City
Beaumont
State/Province
Dublin
ZIP/Postal Code
D09 XR63
Country
Ireland
Facility Name
Kobe City Medical Center General Hospital /ID# 241518
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center /ID# 241986
City
Higashi Ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Okayama Medical Center /ID# 241517
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
National Cancer Center Hospital /ID# 241516
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Samsung Medical Center /ID# 240882
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58260
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Middlemore Clinical Trials /ID# 225596
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
North Shore Hospital /ID# 225597
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Wellington Regional Hospital /ID# 225593
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Pratia MCM Krakow /ID# 218561
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii /ID# 225478
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-776
Country
Poland
Facility Name
SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474
City
Chorzow
State/Province
Slaskie
ZIP/Postal Code
41-500
Country
Poland
Facility Name
IPO Lisboa FG, EPE /ID# 225072
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Regional Oncological Dispensary /ID# 225195
City
Penza
State/Province
Penzenskaya Oblast
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 225476
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Skane University Hospital Lund /ID# 224747
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
SE 221 41
Country
Sweden
Facility Name
China Medical University Hospital /ID# 224945
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 224946
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Ankara Univ Medical Faculty /ID# 225043
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty /ID# 225045
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Vehbi Koc vakfi Amerikan Hasta /ID# 225046
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey
Facility Name
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 240575
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Leicester Royal Infirmary /ID# 240468
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust /ID# 225161
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust /ID# 218736
City
Liverpool
ZIP/Postal Code
L7 8YA
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust /ID# 240467
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 218735
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University Hospital Plymouth NHS Trust /ID# 218731
City
Plymouth
ZIP/Postal Code
PL6 5FP
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust /ID# 225164
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M19-388
Description
Related Info

Learn more about this trial

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

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