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

Primary Purpose

Non-Hodgkin's Lymphoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABT-199

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring ABT-199, Cancer, GDC-0199, non-Hodgkin's lymphoma, Relapsed, Refractory, Safety

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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).

Sites / Locations

University of Arizona Arthritis Center /ID# 101359
Dartmouth-Hitchcock Med Ctr /ID# 92596
Hackensack Univ Med Ctr /ID# 101417

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABT-199

Arm Description

ABT-199 monotherapy

Outcomes

Primary Outcome Measures

Change in cardiac assessment findings

Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram

Percentage of subjects with adverse events

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

Number of subjects with adverse events

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

Change in physical exam finding, including vital signs

Body temperature, weight, blood pressure, heart rate

Secondary Outcome Measures

Full Information

NCT ID

NCT01969695

First Posted

October 22, 2013

Last Updated

December 18, 2019

Sponsor

AbbVie

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01969695

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

December 20, 2013 (Actual)

Primary Completion Date

December 16, 2019 (Actual)

Study Completion Date

December 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkin's Lymphoma

Keywords

ABT-199, Cancer, GDC-0199, non-Hodgkin's lymphoma, Relapsed, Refractory, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABT-199

Arm Type

Experimental

Arm Description

ABT-199 monotherapy

Intervention Type

Drug

Intervention Name(s)

ABT-199

Other Intervention Name(s)

GDC-0199

Intervention Description

ABT-199 continuous once daily dosing

Primary Outcome Measure Information:

Title

Change in cardiac assessment findings

Description

Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram

Time Frame

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

Title

Percentage of subjects with adverse events

Description

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

Time Frame

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

Title

Change in clinical laboratory test results

Description

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

Time Frame

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

Title

Number of subjects with adverse events

Description

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

Time Frame

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

Title

Change in physical exam finding, including vital signs

Description

Body temperature, weight, blood pressure, heart rate

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

University of Arizona Arthritis Center /ID# 101359

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719-1478

Country

United States

Facility Name

Dartmouth-Hitchcock Med Ctr /ID# 92596

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Hackensack Univ Med Ctr /ID# 101417

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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