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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969695
• Other study ID #: M13-835
• Status: Completed
• Phase: Phase 1
• Start date: December 20, 2013
• Est. completion date: December 16, 2019

Study information

• Verified date: December 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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• Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• ABT-199
ABT-199 continuous once daily dosing

Locations

Country	Name	City	State
United States	Hackensack Univ Med Ctr /ID# 101417	Hackensack	New Jersey
United States	Dartmouth-Hitchcock Med Ctr /ID# 92596	Lebanon	New Hampshire
United States	University of Arizona Arthritis Center /ID# 101359	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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