Chronic Lymphocytic LeukemiaPhase 2NCT01557777
Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing Navitoclax in people with Chronic Lymphocytic Leukemia, run by AbbVie (prior sponsor, Abbott) at 15 sites in 5 countries.
Trial summary
Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Navitoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Jun 2012to Jul 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has been dosing in Arm C of the ABT4710n study, has not discontinued for any reason prior to study closure and the investigator believes that continued treatment with navitoclax is in the best interest of the subject
- The subject must meet defined hematology and coagulation lab criteria as specified in the protocol
- The subject must meet defined chemistry criteria as specified in the protocol
- Women of childbearing potential and men must agree to use adequate contraception (as per protocol) prior to study entry, for the duration of study participation and up to 90 days following completion of therapy
- The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign the Informed Consent Form
Who cannot join
- The subject discontinued navitoclax administration in Arm C of the ABT4710n study for reasons of disease progression, Adverse Event toxicity, withdrawal of consent or Investigator decision prior to study completion.
- The subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
- The subject is a lactating or pregnant female.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States5 sites
Site Reference ID/Investigator# 74033
Bethesda, Maryland, 20817
Site Reference ID/Investigator# 74036
La Jolla, California, 92093-0698
Site Reference ID/Investigator# 74035
Los Angeles, California, 90095-7059
Site Reference ID/Investigator# 74038
Pleasant Hill, California, 94523
Site Reference ID/Investigator# 74039
Santa Maria, California, 93454
Ukraine5 sites
Site Reference ID/Investigator# 79203
Ivano-Frankivsk, 76008
Site Reference ID/Investigator# 79205
Khmelnitsky, 29000
Site Reference ID/Investigator# 79202
Kyiv, 03115
Site Reference ID/Investigator# 79204
Lviv, 79044
Site Reference ID/Investigator# 79206
Poltava, 36024
Australia2 sites
Site Reference ID/Investigator# 79201
Coburg, 3058
Site Reference ID/Investigator# 78993
Greenslopes, 4120
Israel2 sites
Site Reference ID/Investigator# 77860
Afula, 18101
Site Reference ID/Investigator# 77637
Rehovot, 76100
About this study
Official title: An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)
Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).
Read the detailed description
This is an open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Navitoclax
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavitoclaxDrug
Also called ABT-263
QD
| Study group | Role | What they receive |
|---|---|---|
| Navitoclax, ABT-263 | Experimental | Not described Receives: Drug: Navitoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.
Measured: Adverse events occuring through the Final Visit (up to Week 52) will be reported
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
Physical exam, blood pressure, pulse, body temperature will be measured and recorded
Measured: Change from baseline through Final Visit (up to Week 52).
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
Chemistry, hematology, urinalysis lab tests will be measured and recorded. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution.
Measured: Change from baseline through Final Visit (up to Week 52).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mack Mabry, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557777
- Sponsor's protocol ID
- M13-641
- Other IDs
- 2012-000606-29
- Status last verified
- Jul 2014
- First submitted
- 16 Mar 2012
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT01557777
- Acronym / sponsor ID
- M13-641
- Conditions
- Chronic Lymphocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Mar 2012 (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.
Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).
Detailed description
This is an open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navitoclax, ABT-263 | Experimental | Drug: Navitoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject has been dosing in Arm C of the ABT4710n study, has not discontinued for any reason prior to study closure and the investigator believes that continued treatment with navitoclax is in the best interest of the subject
- The subject must meet defined hematology and coagulation lab criteria as specified in the protocol
- The subject must meet defined chemistry criteria as specified in the protocol
- Women of childbearing potential and men must agree to use adequate contraception (as per protocol) prior to study entry, for the duration of study participation and up to 90 days following completion of therapy
- The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign the Informed Consent Form
Key exclusion criteria (3 listed)
- The subject discontinued navitoclax administration in Arm C of the ABT4710n study for reasons of disease progression, Adverse Event toxicity, withdrawal of consent or Investigator decision prior to study completion.
- The subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
- The subject is a lactating or pregnant female.
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 |
|---|---|---|
| NavitoclaxAlso: ABT-263QD | Drug | Navitoclax, ABT-263 |
Primary outcome
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
Time frame: Adverse events occuring through the Final Visit (up to Week 52) will be reported
The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
Time frame: Change from baseline through Final Visit (up to Week 52).
Physical exam, blood pressure, pulse, body temperature will be measured and recorded
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
Time frame: Change from baseline through Final Visit (up to Week 52).
Chemistry, hematology, urinalysis lab tests will be measured and recorded. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution.
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 4 Jul 2014.
Related trials for Chronic Lymphocytic Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
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.
Mack Mabry, MD study director
AbbVie
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Navitoclax in people with Chronic Lymphocytic Leukemia, run by AbbVie (prior sponsor, Abbott) at 15 sites in 5 countries.
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 5 inclusion and 3 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 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Ukraine, Australia, Israel, Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. (time frame: Adverse events occuring through the Final Visit (up to Week 52) will be reported). The study lists 3 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 4 Jul 2014.