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NCT Number: NCT01969695

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

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Arizona Arthritis Center /ID# 101359, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 • Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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).

Treatment and study plan

ABT-199

Drug

ABT-199 continuous once daily dosing

Other names: GDC-0199

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2013
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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