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

Phase 1CompletedNCT01969695

AbbVie11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Hodgkin's Lymphoma

Interventions

ABT-199DRUG

ABT-199 continuous once daily dosing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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* Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

Locations (3)

University of Arizona Arthritis Center /ID# 101359

Tucson, Arizona, United States

Dartmouth-Hitchcock Med Ctr /ID# 92596

Lebanon, New Hampshire, United States

Hackensack Univ Med Ctr /ID# 101417

Hackensack, New Jersey, United States

Outcomes

Primary Outcomes

Change in cardiac assessment findings

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

Percentage of subjects with adverse events

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

Change in clinical laboratory test results

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

Number of subjects with adverse events

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

Change in physical exam finding, including vital signs

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

Data from ClinicalTrials.gov

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