Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 198 for:    Venetoclax AND ABT-199

An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01969695
Recruitment Status : Active, not recruiting
First Posted : October 25, 2013
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma [CLL], small lymphocytic lymphoma [SLL], and mantle cell lymphoma [MCL]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study. Subjects will receive ABT-199 during this study.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: ABT-199 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma
Actual Study Start Date : December 20, 2013
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : June 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Venetoclax

Arm Intervention/treatment
Experimental: ABT-199
ABT-199 monotherapy
Drug: ABT-199
ABT-199 continuous once daily dosing
Other Name: GDC-0199




Primary Outcome Measures :
  1. Change in cardiac assessment findings [ Time Frame: Measured from Day 1 up to 6 years after the last subject has enrolled in the study ]
    Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram

  2. Percentage of subjects with adverse events [ Time Frame: Measured up to 6 years after the last subject has enrolled in the study ]
    Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study

  3. Change in clinical laboratory test results [ Time Frame: Measured from Day 1 up to 6 years after the last subject has enrolled in the study ]
    Chemistry, coagulation, hematology, lymphocyte enumeration, paraproteins, urinalysis, and, if appropriate, viral polymerase chain reaction and viral serologies

  4. Number of subjects with adverse events [ Time Frame: Measured up to 6 years after the last subject has enrolled in the study ]
    Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study

  5. Change in physical exam finding, including vital signs [ Time Frame: Measured from Day 1 up to 6 years after the last subject has enrolled in the study ]
    Body temperature, weight, blood pressure, heart rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has completed a prior ABT-199 study (and had met the criteria for a diagnosis of NHL and all other eligibility criteria for the previous study) and the investigator believes that treatment with ABT-199 is in the best interest of the subject.

Exclusion Criteria:

  • Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
  • Subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
  • Subject has not recovered to ≤ Grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy.
  • Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).

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): NCT01969695


Locations
Layout table for location information
United States, Arizona
University Arizona Cancer Ctr /ID# 101359
Tucson, Arizona, United States, 85719-1478
United States, New Hampshire
Dartmouth-Hitchcock Med Ctr /ID# 92596
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack Univ Med Ctr /ID# 101417
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
AbbVie
Genentech, Inc.
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01969695     History of Changes
Other Study ID Numbers: M13-835
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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.: No
Keywords provided by AbbVie:
ABT-199
Cancer
GDC-0199
non-Hodgkin's lymphoma
Relapsed
Refractory
Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Venetoclax
Antineoplastic Agents