NCT01969695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2013

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

December 20, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

6 years

First QC Date

October 22, 2013

Last Update Submit

December 18, 2019

Conditions

Non-Hodgkin's Lymphoma

Keywords

ABT-199CancerGDC-0199non-Hodgkin's lymphomaRelapsedRefractorySafety

Outcome Measures

Primary Outcomes (5)

  • Change in cardiac assessment findings

    Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram

    Measured from Day 1 up to 6 years after the last subject has enrolled in the study

  • Percentage of subjects with adverse events

    Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study

    Measured up to 6 years after the last subject has enrolled in the study

  • Change in clinical laboratory test results

    Chemistry, coagulation, hematology, lymphocyte enumeration, paraproteins, urinalysis, and, if appropriate, viral polymerase chain reaction and viral serologies

    Measured from Day 1 up to 6 years after the last subject has enrolled in the study

  • Number of subjects with adverse events

    Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study

    Measured up to 6 years after the last subject has enrolled in the study

  • Change in physical exam finding, including vital signs

    Body temperature, weight, blood pressure, heart rate

    Measured from Day 1 up to 6 years after the last subject has enrolled in the study

Study Arms (1)

ABT-199

EXPERIMENTAL

ABT-199 monotherapy

Drug: ABT-199

Interventions

ABT-199DRUG

ABT-199 continuous once daily dosing

Also known as: GDC-0199
ABT-199

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Arizona Arthritis Center /ID# 101359

Tucson, Arizona, 85719-1478, United States

Location

Dartmouth-Hitchcock Med Ctr /ID# 92596

Lebanon, New Hampshire, 03756, United States

Location

Hackensack Univ Med Ctr /ID# 101417

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinNeoplasmsRecurrence

Interventions

venetoclax

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 25, 2013

Study Start

December 20, 2013

Primary Completion

December 16, 2019

Study Completion

December 16, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)