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

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

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 Overview

• Status: Completed
• Conditions: Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: ABT-199

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719-1478
      • University of Arizona Arthritis Center /ID# 101359
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Med Ctr /ID# 92596
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Univ Med Ctr /ID# 101417

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2013
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): December 16, 2019

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Cancer; Relapsed; Refractory; ABT-199; GDC-0199; non-Hodgkin's lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Antineoplastic Agents; Venetoclax
• Other Study ID Numbers: M13-835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No