Non-Hodgkin's LymphomaPhase 1NCT01969695
An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma
A Phase 1 study testing ABT-199 in people with Non-Hodgkin's Lymphoma, run by AbbVie at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- ABT-199
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Dec 2013to 16 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hackensack Univ Med Ctr /ID# 101417
Hackensack, New Jersey, 07601
Dartmouth-Hitchcock Med Ctr /ID# 92596
Lebanon, New Hampshire, 03756
University of Arizona Arthritis Center /ID# 101359
Tucson, Arizona, 85719-1478
About this study
Official title: 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.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- ABT-199
- Keywords
- ABT-199, Cancer, GDC-0199, non-Hodgkin's lymphoma, Relapsed, Refractory, Safety
- Medical subject headings
- Lymphoma, Non-Hodgkin, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-199Drug
Also called GDC-0199
ABT-199 continuous once daily dosing
| Study group | Role | What they receive |
|---|---|---|
| ABT-199 | Experimental | ABT-199 monotherapy Receives: Drug: ABT-199 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac assessment findings
Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram
Measured: 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: 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: 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: 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: Measured from Day 1 up to 6 years after the last subject has enrolled in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study start20 Dec 2013
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969695
- Sponsor's protocol ID
- M13-835
- Status last verified
- Dec 2019
- First submitted
- 22 Oct 2013
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01969695
- Acronym / sponsor ID
- M13-835
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- ABT-199, Cancer, GDC-0199, non-Hodgkin's lymphoma, Relapsed, Refractory, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- 20 Dec 2013 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT-199 | Experimental | Drug: ABT-199ABT-199 monotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-199Also: GDC-0199ABT-199 continuous once daily dosing | Drug | ABT-199 |
Primary outcome
Change in cardiac assessment findings
Time frame: 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
Time frame: 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 clinical laboratory test results
Time frame: 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
Time frame: 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
Time frame: Measured from Day 1 up to 6 years after the last subject has enrolled in the study
Body temperature, weight, blood pressure, heart rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-199 in people with Non-Hodgkin's Lymphoma, run by AbbVie at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac assessment findings (time frame: Measured from Day 1 up to 6 years after the last subject has enrolled in the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.