Clinical trial NCT01969695: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin's Lymphoma
Keywords: ABT-199
Cancer
GDC-0199
non-Hodgkin's lymphoma
Relapsed
Refractory
Safety
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2013-10-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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* Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

Primary outcomes:
measure: Change in cardiac assessment findings
timeFrame: Measured from Day 1 up to 6 years after the last subject has enrolled in the study
measure: Percentage of subjects with adverse events
timeFrame: Measured up to 6 years after the last subject has enrolled in the study
measure: Change in clinical laboratory test results
timeFrame: Measured from Day 1 up to 6 years after the last subject has enrolled in the study
measure: Number of subjects with adverse events
timeFrame: Measured up to 6 years after the last subject has enrolled in the study
measure: Change in physical exam finding, including vital signs
timeFrame: Measured from Day 1 up to 6 years after the last subject has enrolled in the study
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Arthritis Center /ID# 101359
state: Arizona
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Med Ctr /ID# 92596
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack Univ Med Ctr /ID# 101417
state: New Jersey
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: