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

Phase 1

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: ABT-199

• Registration Number: NCT01969695
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-25
• Study Start: 2013-12-20
• Status Verified: 2019-12
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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• Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABT-199	ABT-199	ABT-199 monotherapy

Primary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

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