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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT01969695

Collaborator

Genentech, Inc. (Industry)

Enrollment

Locations

Arm

71.9

Actual Duration (Months)

3.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

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 :

Dec 20, 2013

Actual Primary Completion Date :

Dec 16, 2019

Actual Study Completion Date :

Dec 16, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: ABT-199

ABT-199 monotherapy

Drug: ABT-199

ABT-199 continuous once daily dosing

Other Names:

GDC-0199

Outcome Measures

Primary Outcome Measures

Change in cardiac assessment findings [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
Percentage of subjects with adverse events [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
Change in clinical laboratory test results [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
Number of subjects with adverse events [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
Change in physical exam finding, including vital signs [Measured from Day 1 up to 6 years after the last subject has enrolled in the study]
Body temperature, weight, blood pressure, heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Arthritis Center /ID# 101359	Tucson	Arizona	United States	85719-1478
2	Dartmouth-Hitchcock Med Ctr /ID# 92596	Lebanon	New Hampshire	United States	03756
3	Hackensack Univ Med Ctr /ID# 101417	Hackensack	New Jersey	United States	07601