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
52
Locations
1
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.

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

ArmIntervention/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

    1. 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:
    No
    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

    SiteCityStateCountryPostal Code
    1University of Arizona Cancer Center - Tucson /ID# 210548TucsonArizonaUnited States85724
    2UCLA Santa Monica Hematology Oncology /ID# 210551Los AngelesCaliforniaUnited States90095
    3Ingalls Memorial Hosp /ID# 210553HarveyIllinoisUnited States60426
    4Dana-Farber Cancer Institute /ID# 215360BostonMassachusettsUnited States02215
    5University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132Ann ArborMichiganUnited States48109
    6Dartmouth-Hitchcock Medical Center /ID# 210555LebanonNew HampshireUnited States03756
    7Duplicate_Gabrail Cancer Center Research /ID# 212061CantonOhioUnited States44718
    8Swedish Cancer Institute - Edmonds /ID# 213120SeattleWashingtonUnited States98104
    9Royal Prince Alfred Hospital /ID# 239557CamperdownNew South WalesAustralia2050
    10The Kinghorn Cancer Centre /ID# 241675DarlinghurstNew South WalesAustralia2010
    11St George Hospital /ID# 225589KogarahNew South WalesAustralia2217
    12Liverpool Hospital /ID# 225591LiverpoolNew South WalesAustralia2170
    13Peter MacCallum Cancer Ctr /ID# 210559MelbourneVictoriaAustralia3000
    14Fiona Stanley Hospital /ID# 239480MurdochWestern AustraliaAustralia6150
    15Perth Blood Institute Ltd /ID# 225592NedlandsWestern AustraliaAustralia6009
    16Medizinische Universitaet Graz /ID# 223817GrazSteiermarkAustria8036
    17UCL Saint-Luc /ID# 224327Woluwe-Saint-LambertBruxelles-CapitaleBelgium1200
    18CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616Quebec CityQuebecCanadaG1J 1Z4
    19Rigshospitalet /ID# 224213Copenhagen ØHovedstadenDenmark2100
    20Aarhus University Hospital /ID# 224214Aarhus NMidtjyllandDenmark8200
    21HCL - Hôpital Lyon Sud /ID# 213508Pierre Benite CEDEXAuvergne-Rhone-AlpesFrance69495
    22General Hospital of Athens Laiko /ID# 224087AthensAttikiGreece11527
    23General Hospital of Thessaloniki George Papanikolaou /ID# 224088ThessalonikiGreece57010
    24Queen Mary Hospital /ID# 224944Hong KongHong Kong999077
    25Beaumont Hospital /ID# 225165BeaumontDublinIrelandD09 XR63
    26Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018MoreliaMichoacanMexico58260
    27Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017MonterreyNuevo LeonMexico64460
    28Middlemore Clinical Trials /ID# 225596PapatoetoeAucklandNew Zealand2025
    29North Shore Hospital /ID# 225597TakapunaAucklandNew Zealand0622
    30Wellington Regional Hospital /ID# 225593NewtownWellingtonNew Zealand6021
    31Pratia MCM Krakow /ID# 218561KrakowMalopolskiePoland30-510
    32Instytut Hematologii i Transfuzjologii /ID# 225478WarszawaMazowieckiePoland02-776
    33SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474ChorzowSlaskiePoland41-500
    34IPO Lisboa FG, EPE /ID# 225072LisboaPortugal1099-023
    35Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194MoscowMoskvaRussian Federation115478
    36Regional Oncological Dispensary /ID# 225195PenzaPenzenskaya OblastRussian Federation440071
    37Hospital Universitario Fundacion Jimenez Diaz /ID# 225476MadridSpain28040
    38Skane University Hospital Lund /ID# 224747LundSkane LanSwedenSE 221 41
    39China Medical University Hospital /ID# 224945Taichung CityTaiwan40447
    40National Taiwan University Hospital /ID# 224946Taipei CityTaiwan100
    41Ankara Univ Medical Faculty /ID# 225043AnkaraTurkey06590
    42Istanbul University Istanbul Medical Faculty /ID# 225045IstanbulTurkey34093
    43Vehbi Koc vakfi Amerikan Hasta /ID# 225046IstanbulTurkey34365
    44Dokuz Eylul University Medical Faculty /ID# 225044IzmirTurkey35340
    45Ondokuz mayis University Facul /ID# 225042SamsunTurkey55200
    46University Hospitals Bristol NHS Foundation Trust /ID# 225162BristolBristol, City OfUnited KingdomBS1 3NU
    47University Hospital Southampton NHS Foundation Trust /ID# 225161SouthamptonHampshireUnited KingdomSO16 6YD
    48Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163BlackpoolUnited KingdomFY3 8NR
    49The Clatterbridge Cancer Centre NHS Foundation Trust /ID# 218736LiverpoolUnited KingdomL7 8YA
    50King's College Hospital NHS Foundation Trusts /ID# 218735LondonUnited KingdomSE5 9RS
    51University Hospital Plymouth NHS Trust /ID# 218731PlymouthUnited KingdomPL6 5FP
    52The Royal Wolverhampton NHS Trust /ID# 225164WolverhamptonUnited KingdomWV10 0QP

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03844048
    Other Study ID Numbers:
    • M19-388
    • 2018-004356-38
    First Posted:
    Feb 18, 2019
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 23, 2021