Small Lymphocytic LymphomaPhase 1NCT01682616
A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
A Phase 1 study testing ABT-199 and Rituximab in people with Small Lymphocytic Lymphoma and Chronic Lymphocytic Leukemia, run by AbbVie at 6 sites in 2 countries.
Trial summary
This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- ABT-199 and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 25 Jul 2012to 23 Jun 2022
- 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 must be greater then or equal to 18 years of age.
- Subject must have relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
- Subject has an Eastern Cooperative Oncology Group performance score of less than or equal to 1.
- Subject must have adequate bone marrow independent of growth factor support per local laboratory reference range at Screening.
- Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening.
Who cannot join
- Chronic lymphocytic leukemia or Small Lymphocytic Lymphoma subject has undergone an allogeneic or autologous stem cell transplant.
- Subject has uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- Subject has tested positive for human immunodeficiency virus.
- Seropositivity for hepatitis B surface antigen or hepatitis C virus antibody or ribonucleic acid.
- History of severe allergic or anaphylactic reactions to rituximab.
- Subject has received a live viral vaccine within 6 months prior to the first dose of study drug.
Show all 20Show fewer
- Subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.
- Subject has received any of the following within 14 days prior to the first dose of study drug, or has not recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
- Any anti-cancer therapy including chemotherapy, immunotherapy, or radiotherapy;
- Investigational therapy, including targeted small molecule agents.
- Subject has a cardiovascular disability status of New York Heart Association Class greater then or equal to 2. Class 2 is defined as cardiac disease in which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain.
- Subject has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
- Subject has a history of other active malignancies other than CLL/SLL within the past 2 years prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- Subject has malabsorption syndrome or other condition that precludes enteral route of administration.
- Subject exhibits evidence of other clinically significant ongoing or recent condition(s) including, but not limited to:
- Ongoing systemic infection (viral, bacterial, or fungal);
- Diagnosis of fever and neutropenia within 1 week prior to study drug administration
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Northwestern University Feinberg School of Medicine /ID# 71593
Chicago, Illinois, 60611-2927
Duke Cancer Center /ID# 71393
Durham, North Carolina, 27710-3000
Moores Cancer Center at UC San Diego /ID# 70398
La Jolla, California, 92093
North Shore University Hospital /ID# 71813
New Hyde Park, New York, 11040
Australia2 sites
Peter MacCallum Cancer Ctr /ID# 70394
Melbourne, Victoria, 3000
The Royal Melbourne Hospital /ID# 70393
Parkville, Victoria, 3050
About this study
This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to determine the maximum tolerated dose and establish the Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose escalation portion of the study will include approximately 30 subjects. Once the recommended phase two dose and schedule have been determined, up to 20 additional subjects will be enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi, or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs, as defined by iwCLL NCI/WG criteria for tumor response, or MRD progression, subjects may re-initiate ABT-199.
- Being tested
- ABT-199, Rituximab
- Keywords
- Safety, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Rituximab, Tolerability, Pharmacokinetics, ABT-199, Cancer, Preliminary, Efficacy, Maximum Tolerated Dose, Venetoclax
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-199Drug
Also called venetoclax
ABT-199 is taken continuously once daily. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study.
RituximabDrug
Rituximab will be given by intravenous infusion on day 1 of Months 1, 2, 3, 4, 5, and 6. May be reinitiated for an additional 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) Receives: Drug: ABT-199; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety profile, to determine the maximum tolerated dose and Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab (R) in subjects with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma.
Protocol-defined events, which are attributed as having a reasonable possibility of being related to the administration of ABT-199 and/or rituximab, or can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, concurrent illness, underlying disease or concomitant medication, will be considered a dose limiting toxicity.
Measured: Continuous dosing at designated dose level up to Month 6. At end of combination treatment, ABT-199 monotherapy may continue up to 8 years following the date of the last subject enrolled. If disease progression occurs, subjects may re-initiate ABT-199.
Secondary outcomes (8)
Determination of peak concentration (Cmax) of ABT-199 and/or Rituximab.
Blood samples for analysis of ABT-199 and rituximab will be collected at designated time points.
Measured: PK samples collected up to Month 6 for ABT-199 and Rituximab
Assess the exploratory efficacy of the combination ABT-199 and rituximab.
Tumor response or clinical disease progression (Objective Response Rate)
Measured: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
Determination of trough concentration (Ctrough) of ABT-199 and/or Rituximab
Blood samples for analysis of ABT-199 and rituximab will be collected at designated time points.
Measured: PK samples collected up to Month 6 for ABT-199 and Rituximab
Determination of area under the concentration versus time curve (AUC) of ABT-199 and/or Rituximab
Blood samples for analysis of ABT-199 and rituximab will be collected at designated time points.
Measured: PK samples collected up to Month 6 for ABT-199 and Rituximab
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Tumor response or clinical disease progression for (Overall Survival)
Measured: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Tumor response or clinical disease progression for (Progression Free Survival)
Measured: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Tumor response or clinical disease progression for (Time to Tumor Progression)
Measured: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Tumor response or clinical disease progression for (Duration Of Response)
Measured: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study start25 Jul 2012
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Small Lymphocytic 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
- 49 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
- NCT01682616
- Sponsor's protocol ID
- M13-365
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2012
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.
PubMed 35829925Roberts AW, Ma S, Kipps TJ, Coutre SE, Davids MS, Eichhorst B, Hallek M, Byrd JC, Humphrey K, Zhou L, Chyla B, Nielsen J, Potluri J, Kim SY, Verdugo M, Stilgenbauer S, Wierda WG, Seymour JF. Efficacy of venetoclax in relapsed chronic lymphocytic leukemia is influenced by disease and response variables. Blood. 2019 Jul 11;134(2):111-122. doi: 10.1182/blood.2018882555. Epub 2019 Apr 25.
PubMed 31023700Seymour JF, Ma S, Brander DM, Choi MY, Barrientos J, Davids MS, Anderson MA, Beaven AW, Rosen ST, Tam CS, Prine B, Agarwal SK, Munasinghe W, Zhu M, Lash LL, Desai M, Cerri E, Verdugo M, Kim SY, Humerickhouse RA, Gordon GB, Kipps TJ, Roberts AW. Venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukaemia: a phase 1b study. Lancet Oncol. 2017 Feb;18(2):230-240. doi: 10.1016/S1470-2045(17)30012-8. Epub 2017 Jan 13.
PubMed 28089635
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT01682616
- Acronym / sponsor ID
- M13-365
- Keywords
- Safety, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Rituximab, Tolerability, Pharmacokinetics, ABT-199, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- 25 Jul 2012 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 11 Sep 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.
This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to determine the maximum tolerated dose and establish the Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose escalation portion of the study will include approximately 30 subjects. Once the recommended phase two dose and schedule have been determined, up to 20 additional subjects will be enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi, or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs, as defined by iwCLL NCI/WG criteria for tumor response, or MRD progression, subjects may re-initiate ABT-199.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: ABT-199, Drug: RituximabChronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must be greater then or equal to 18 years of age.
- Subject must have relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
- Subject has an Eastern Cooperative Oncology Group performance score of less than or equal to 1.
- Subject must have adequate bone marrow independent of growth factor support per local laboratory reference range at Screening.
- Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening.
Key exclusion criteria (20 listed)
- Chronic lymphocytic leukemia or Small Lymphocytic Lymphoma subject has undergone an allogeneic or autologous stem cell transplant.
- Subject has uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- Subject has tested positive for human immunodeficiency virus.
- Seropositivity for hepatitis B surface antigen or hepatitis C virus antibody or ribonucleic acid.
- History of severe allergic or anaphylactic reactions to rituximab.
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: venetoclaxABT-199 is taken continuously once daily. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study. | Drug | Arm 1 |
| RituximabRituximab will be given by intravenous infusion on day 1 of Months 1, 2, 3, 4, 5, and 6. May be reinitiated for an additional 6 months. | Drug | Arm 1 |
Primary outcome
Assess the safety profile, to determine the maximum tolerated dose and Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab (R) in subjects with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma.
Time frame: Continuous dosing at designated dose level up to Month 6. At end of combination treatment, ABT-199 monotherapy may continue up to 8 years following the date of the last subject enrolled. If disease progression occurs, subjects may re-initiate ABT-199.
Protocol-defined events, which are attributed as having a reasonable possibility of being related to the administration of ABT-199 and/or rituximab, or can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, concurrent illness, underlying disease or concomitant medication, will be considered a dose limiting toxicity.
8 secondary outcomes
Determination of peak concentration (Cmax) of ABT-199 and/or Rituximab.
Time frame: PK samples collected up to Month 6 for ABT-199 and Rituximab
Assess the exploratory efficacy of the combination ABT-199 and rituximab.
Time frame: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
Determination of trough concentration (Ctrough) of ABT-199 and/or Rituximab
Time frame: PK samples collected up to Month 6 for ABT-199 and Rituximab
Determination of area under the concentration versus time curve (AUC) of ABT-199 and/or Rituximab
Time frame: PK samples collected up to Month 6 for ABT-199 and Rituximab
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Time frame: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Time frame: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Time frame: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Time frame: Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
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 6 Jun 2023.
- Derived from this study: PubMed 35829925Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.
- Derived from this study: PubMed 31023700Roberts AW, Ma S, Kipps TJ, Coutre SE, Davids MS, Eichhorst B, Hallek M, Byrd JC, Humphrey K, Zhou L, Chyla B, Nielsen J, Potluri J, Kim SY, Verdugo M, Stilgenbauer S, Wierda WG, Seymour JF. Efficacy of venetoclax in relapsed chronic lymphocytic leukemia is influenced by disease and response variables. Blood. 2019 Jul 11;134(2):111-122. doi: 10.1182/blood.2018882555. Epub 2019 Apr 25.
- Derived from this study: PubMed 28089635Seymour JF, Ma S, Brander DM, Choi MY, Barrientos J, Davids MS, Anderson MA, Beaven AW, Rosen ST, Tam CS, Prine B, Agarwal SK, Munasinghe W, Zhu M, Lash LL, Desai M, Cerri E, Verdugo M, Kim SY, Humerickhouse RA, Gordon GB, Kipps TJ, Roberts AW. Venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukaemia: a phase 1b study. Lancet Oncol. 2017 Feb;18(2):230-240. doi: 10.1016/S1470-2045(17)30012-8. Epub 2017 Jan 13.
- Individual participant dataSharing planned: No
Related trials for Small Lymphocytic Lymphoma
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
Active, not recruitingPhase 1
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, B-Cell Prolymphocytic Leukemia
RecruitingPhase 3
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
RecruitingPhase 2
Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
RecruitingPhase 1/2
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
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
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-199 and Rituximab in people with Small Lymphocytic Lymphoma and Chronic Lymphocytic Leukemia, run by AbbVie at 6 sites in 2 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 20 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 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. 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?
Assess the safety profile, to determine the maximum tolerated dose and Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab (R) in subjects with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma. (time frame: Continuous dosing at designated dose level up to Month 6. At end of combination treatment, ABT-199 monotherapy may continue up to 8 years following the date of the last subject enrolled. If disease progression occurs, subjects may re-initiate ABT-199.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01682616, which also lists 3 linked publications.
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 6 Jun 2023.