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

NCT ID: NCT01969695

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-20

Study Completion Date

2019-12-16

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-199

ABT-199 monotherapy

Group Type EXPERIMENTAL

ABT-199

Intervention Type DRUG

ABT-199 continuous once daily dosing

Interventions

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ABT-199

ABT-199 continuous once daily dosing

Intervention Type DRUG

Other Intervention Names

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GDC-0199

Eligibility Criteria

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* Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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University of Arizona Arthritis Center /ID# 101359

Tucson, Arizona, United States

Site Status

Dartmouth-Hitchcock Med Ctr /ID# 92596

Lebanon, New Hampshire, United States

Site Status

Hackensack Univ Med Ctr /ID# 101417

Hackensack, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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M13-835

Identifier Type: -

Identifier Source: org_study_id