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Trial record 15 of 182 for:    Venetoclax

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

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ClinicalTrials.gov Identifier: NCT03844048
Recruitment Status : Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
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
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : January 19, 2025
Estimated Study Completion Date : January 19, 2025


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 Name: ABT-199




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844048


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Arizona
University Arizona Cancer Ctr /ID# 210548 Not yet recruiting
Tucson, Arizona, United States, 85719-1478
United States, Michigan
Henry Ford Health System /ID# 210557 Not yet recruiting
Detroit, Michigan, United States, 48202
United States, New Hampshire
Dartmouth-Hitchock Med Ctr /ID# 210555 Not yet recruiting
Lebanon, New Hampshire, United States, 03756
United States, Ohio
Clinical Research Trials (CRT) /ID# 212061 Not yet recruiting
Canton, Ohio, United States, 44718
Australia, Victoria
Peter MacCallum Cancer Ctr /ID# 210559 Not yet recruiting
Melbourne, Victoria, Australia, 3000
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03844048     History of Changes
Other Study ID Numbers: M19-388
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 and 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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:
Chronic Lymphocytic Leukemia (CLL)
Acute Myeloid Leukemia (AML)
Multiple Myeloma (MM)
Non-Hodgkin's Lymphoma (NHL)
Acute Lymphoblastic Leukemia (ALL)
Cancer
Venetoclax

Additional relevant MeSH terms:
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Venetoclax
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Lymphatic Diseases
Leukemia, B-Cell
Antineoplastic Agents