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Chronic Lymphocytic LeukemiaPhase 2NCT01889186

A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion

A Phase 2 study testing ABT-199 (Main Cohort) and ABT-199 (Safety Expansion Cohort) in people with Chronic Lymphocytic Leukemia and 17p Deletion, run by AbbVie at 48 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This was an open-label, multicenter, global study to determine the efficacy of ABT-199 (Venetoclax) monotherapy in participants with relapsed/refractory (R/R) or previously untreated chronic lymphocytic leukemia (CLL) harboring 17p deletion. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
ABT-199 (Main Cohort) and ABT-199 (Safety Expansion Cohort)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
48 sitesin 7 countries
Study dates
27 Jun 2013to 15 Dec 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participant must be greater than or equal to 18 years of age.
  • Participant must have diagnosis of chronic lymphocytic leukemia (CLL) that meets published 2008 Modified IWCLL NCI-WG (International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group) Guidelines.
  • Participant has an indication for treatment according to the 2008 Modified IWCLL NCI WG Guidelines;
  • Participant has clinically measurable disease (lymphocytosis > 5 × 10^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam);
  • Participant must be refractory or have relapsed after receiving at least one prior line of therapy (participants that have progressed after 1 cycle of treatment or have completed at least 2 cycles of treatment for a given line of therapy) or previously untreated CLL (previously untreated CLL participants must have received no prior chemotherapy or immunotherapy. Participants with a history of emergency, loco-regional radiotherapy (e.g., for relief of compressive signs or symptoms) are eligible. In addition, participants must meet the CLL diagnostic criteria above and must have > 5 × 10^9/L B-Lymphocytes in the peripheral blood.);
  • Participants must have 17p deletion, assessed by local laboratory (in bone marrow or peripheral blood) or assessed by central laboratory (peripheral blood).
Show all 17Show fewer
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
  • Participant must have adequate bone marrow function at Screening as follows:
  • Absolute Neutrophil Count (ANC) greater than or equal to 1000/µL, or
  • For subjects with an ANC less than 1000/µL at Screening and bone marrow heavily infiltrated with underlying disease (unless cytopenia is clearly due to marrow involvement of CLL), growth factor support may be administered after Screening and prior to the first dose of ABT-199 to achieve the ANC eligibility criteria (greater than or equal to 1000/µL);
  • Platelets greater than 30,000/mm^3 (without transfusion support within 14 days of Screening, without evidence of mucosal bleeding, without known history of bleeding episode within 3 months of Screening, and without history of bleeding disorder);
  • Hemoglobin greater than or equal to 8.0 g/dL.
  • Participant must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows:
  • Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 × the upper limit of normal;
  • Calculated creatinine clearance greater than 50 mL/min using 24-hour Creatinine Clearance or modified Cockcroft-Gault equation (using Ideal Body Mass [IBM] instead of Mass). For participants that have body mass index (BMI) of > 30 kg/m^2 or < 19 kg/m^2, 24-hour measured urine creatinine clearance is required;
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3.0 × the upper normal limit of institution's normal range; Bilirubin less than or equal to 1.5 × upper limit of normal. Participants with Gilbert's Syndrome may have a bilirubin greater 1.5 × upper limit of normal, per correspondence between the investigator and AbbVie medical monitor.
  • For participants at high risk of tumor lysis syndrome a pre-approval by the AbbVie medical monitor is required prior to enrollment.

Who cannot join

  • Participant has undergone an allogeneic stem cell transplant.
  • Participant has developed Richter's transformation confirmed by biopsy.
  • Participant has prolymphocytic leukemia.
  • Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura despite low dose corticosteroids.
  • Participant has previously received ABT-199.
  • Participant has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
Show all 10Show fewer
  • Participant has received any of the following within 14 days or 5 half-lives as applicable prior to the first dose of study drug, or has not recovered to less than Common Toxicity Criteria (CTC) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
  • Any anti-cancer therapy including chemotherapy, or radiotherapy;
  • Investigational therapy, including targeted small molecule agents.
  • Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.

Trial locations and contacts

48 sites in 7 countries.

48 sites in 7 countries

United States16 sites

  • Dana-Farber Cancer Institute /ID# 92494

    Boston, Massachusetts, 02215

  • Northwestern University Feinberg School of Medicine /ID# 92499

    Chicago, Illinois, 60611-2927

  • The University of Chicago Medical Center /ID# 96960

    Chicago, Illinois, 60637-1443

  • Cleveland Clinic Main Campus /ID# 92495

    Cleveland, Ohio, 44195

  • Henry Ford Health System /ID# 97795

    Detroit, Michigan, 48202

  • City of Hope /ID# 112875

    Duarte, California, 91010

  • Hackensack Univ Med Ctr /ID# 92500

    Hackensack, New Jersey, 07601

  • Ingalls Memorial Hosp /ID# 92497

    Harvey, Illinois, 60426

  • University of Texas MD Anderson Cancer Center /ID# 92521

    Houston, Texas, 77030

  • Moore UC San Diego Cancer Center /ID# 91793

    La Jolla, California, 92093

  • Rutgers Cancer Institute of New Jersey /ID# 92513

    New Brunswick, New Jersey, 08903

  • Columbia Univ Medical Center /ID# 103835

    New York, New York, 10032-3725

  • Columbia Univ Medical Center /ID# 94716

    New York, New York, 10032-3725

  • Stanford University School of Med /ID# 105117

    Stanford, California, 94305-2200

  • University of Arizona Cancer Center - North Campus /ID# 96748

    Tucson, Arizona, 85719-1478

  • Georgetown University Hospital /ID# 96954

    Washington D.C., District of Columbia, 20007

Other trials in United States

United Kingdom11 sites

  • The Royal Bournemouth Hospital /ID# 118975

    Bournemouth, BH7 7DW

  • Addenbrookes Hospital /ID# 119977

    Cambridge, CB2 0SP

  • St. James University Hospital /ID# 98863

    Leeds, LS9 7TF

  • Leicester Royal Infirmary /ID# 98865

    Leicester, England, LE1 5WW

  • Royal Liverpool and Broadgreen /ID# 98860

    Liverpool, L7 8XP

  • St Bartholomew's Hospital, Bar /ID# 98862

    London, EC1A 7BE

  • King's College Hospital NHS Foundation Trust /ID# 119975

    London, SE5 9RS

  • The Christie Hospital /ID# 98864

    Manchester, M20 4BX

  • Oxford Univ Hosp NHS Trust /ID# 119976

    Oxford, OX3 7LE

  • Derriford Hospital /ID# 118335

    Plymouth, PL6 8DH

  • Royal Marsden Hospital /ID# 98861

    Sutton, SM2 5PT

Other trials in United Kingdom

Germany9 sites

  • Uniklinik Koeln /ID# 98847

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 113256

    Dresden, 01307

  • Universitaetsklinikum Freiburg /ID# 113276

    Freiburg im Breisgau, 79106

  • Universitaetsmedizin Goettingen /ID# 113258

    Göttingen, 37075

  • Universitaetsklinik Heidelberg /ID# 98845

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 113235

    Kiel, Schleswig-Holstein, 24105

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 113236

    Mainz, 55131

  • Muenchen Klinik Schwabing /ID# 113275

    München, 80804

  • Universitaetsklinikum Ulm /ID# 92533

    Ulm, Thuringia, 89081

Other trials in Germany

Australia4 sites

  • John Fawkner Private Hospital /ID# 98835

    Coburg, Victoria, 3058

  • Peter MacCallum Cancer Ctr /ID# 91795

    Melbourne, Victoria, 3000

  • Royal Melbourne Hospital /ID# 91794

    Parkville, Victoria, 3050

  • Royal North Shore Hospital /ID# 98836

    St Leonards, New South Wales, 2065

Other trials in Australia

France4 sites

  • Hopital Avicenne - APHP /ID# 98840

    Bobigny, Île-de-France Region, 93000

  • Hopital Pitie Salpetriere /ID# 98842

    Paris, 75651

  • Centre Hospitalier Lyon Sud /ID# 98839

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Centre Henri Becquerel /ID# 98838

    Rouen, 76038

Other trials in France

Poland3 sites

  • SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 98849

    Krakow, Lesser Poland Voivodeship, 31-501

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 98848

    Lublin, Lublin Voivodeship, 20-081

  • Szpital Wojewodzki w Opolu /ID# 102855

    Opole, Opole Voivodeship, 46-020

Other trials in Poland

Canada1 site

  • Duplicate_Jewish General Hospital /ID# 99476

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia Harboring the 17p Deletion

This was an open-label, multicenter, global study to determine the efficacy of ABT-199 (Venetoclax) monotherapy in participants with relapsed/refractory (R/R) or previously untreated chronic lymphocytic leukemia (CLL) harboring 17p deletion.

Read the detailed description

This study was designed to enroll approximately 150 participants in 2 cohorts: a main cohort of approximately 100 participants, and a safety expansion (SE) cohort of approximately 50 participants. The primary objective of the main cohort was to evaluate the efficacy of ABT-199 monotherapy in participants with R/R CLL harboring the 17p deletion. The primary objective of the safety expansion cohort was to evaluate the safety of ABT-199 in approximately 50 participants with R/R CLL harboring 17p deletion treated per updated tumor lysis syndrome (TLS) prophylaxis and management measures.

Being tested
ABT-199 (Main Cohort), ABT-199 (Safety Expansion Cohort)
Keywords
Chronic Lymphocytic Leukemia, 17p Deletion
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Chromosome 17 deletion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-199 (Main Cohort)Drug

    Also called Venetoclax, GDC-0199

    Participants received a test dose of ABT-199 of ≤ 20 mg on Week 1 Day 1 of the Lead-In Period. For those with significant electrolyte and/or lymphocyte changes within 24 hours of the first dose, the 20 mg dose was maintained for 7 days with escalation to 50 mg on Week 2 Day 1. If none of the electrolyte and/or lymphocyte changes occurred within 24 hours from ABT-199 20 mg dose administration, the participant was dose-escalated to 50 mg on Week 1 Day 2. After the first dose of 50 mg, if no laboratory abnormalities occurred, the participant remained on the 50 mg dose through Week 1. After receiving the 50 mg dose for approximately 1 week (6 to 7 days), the following dose escalation proceeded with weekly increases in dose: → 100 mg → 200 mg → 400 mg (or additional lead-in steps to designated 400 mg dose), as tolerated.

  • ABT-199 (Safety Expansion Cohort)Drug

    Also called Venetoclax, GDC-0199

    Participants received an initial dose of ABT-199 of 20 mg on Week 1 Day 1 of the Lead-In Period. If one or more electrolyte changes (from the 0 hr measurement prior to dosing) suggestive of laboratory tumor lysis syndrome (LTLS) or clinical TLS (CTLS) occurred within 24 hours of the 20 mg dose, no additional doses were administered until resolution. Upon resolution of laboratory abnormalities, the 20 mg dose was continued through Week 1. If no significant findings suggestive of clinical or laboratory TLS occurred within 24 hours, the 20 mg dose was continued through Week 1 Day 7, and escalated to a dose of 50 mg on Week 2 Day 1. Those who had drug interruptions may have been allowed to escalate to and be maintained at 50 mg for 1 week after they had been on a 20 mg dose for at least 1 week (5 - 7 days). After a week at 50 mg, weekly dose escalations were implemented as follows: 100 mg → 200 mg → 400 mg (or additional lead-in steps to designated 400 mg dose) as tolerated.

Study groups in NCT01889186
Study groupRoleWhat they receive
Main CohortExperimentalParticipants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Receives: Drug: ABT-199 (Main Cohort)
Safety Expansion CohortExperimentalParticipants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Receives: Drug: ABT-199 (Safety Expansion Cohort)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (Main Cohort)

    The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria as assessed by the Independent Review Committee (IRC) in the first 70 participants treated in the Main Cohort.

    Measured: Up to 36 weeks

  2. Number of Participants With Adverse Events (Safety Expansion Cohort)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

    Measured: From the first dose of study drug until 30 days following last dose of study drug (up to 69 months)

Secondary outcomes (11)

  1. Overall Response Rate (ORR) (Safety Expansion Cohort)

    The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

  2. Complete Remission (CR) Rate

    Complete remission was defined as the proportion of participants who achieved a CR or Complete Remission with Incomplete Marrow Recovery(CRi ) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a CR or CRi were considered to be non-responders in the calculation of CR rate.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

  3. Partial Remission (PR) Rate

    PR rate was defined as the proportion of participants who achieved a nodular partial remission (nPR) or PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a nPR or PR were considered to be non-responders in the calculation of PR rate.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

  4. Duration of Overall Response

    Duration of overall response (DoR) was defined as the number of days from the date of first response (CR, CRi, nPR, or PR) by either CT scan or physical exam determination to the earliest recurrence (progressive disease; PD) or death. For participants who had a PR before CR, CRi, or nPR in subsequent visits, the DoR was computed from the earliest PR. If a participant was still responding, then their data was censored at the date of their last available disease assessment. To be included in the DoR analysis, participants must have had a response per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria (CR, CRi, confirmed nPR, or confirmed PR). For participants who never experienced response, their data was not included in the analysis.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

  5. Progression-free Survival

    Duration of progression-free survival (PFS) was defined as the number of days from the date of first dose to the date of earliest disease progression or death. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant does not experience disease progression or death, then the data was censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

  6. Event-free Survival

    Event-free survival (EFS) was defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy. If the specified event (disease progression, death, start of a new anti-leukemic treatment) did not occur, participants were censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

  7. Time to Progression

    Time to progression (TTP) was defined as the number of days from the date of first dose to the date of earliest disease progression. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant did not experience disease progression, then the data was censored at the date of last available disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

  8. Time to First Response

    Time to first response was defined as the number of days from the date of first dose to the date of the first sign of response (CR, CRi, nPR, or PR) given the participant has had a CR, CRi, confirmed nPR, or confirmed PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. The first response could have been an assessment by physical exam as long as the results were later confirmed per the 2008 Modified IWCLL NCI-WG criteria. For participants who never experienced a response, the participant's data were not included in the analysis.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

  9. Time to 50% Reduction in Absolute Lymphocyte Count

    Time to 50% reduction in absolute lymphocyte count (ALC) was defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC had reduced to 50% of the baseline value. Only participants with a baseline of ALC > 5 × 10^9 /L were included in the analysis. For participants who never achieved a 50% reduction in ALC, the participant's data were not included in the analysis.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

  10. Overall Survival

    Overall survival (OS) was defined as number of days from the date of first dose to the date of death. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later.

    Measured: Up to the data cutoff date of 15 December 2020, approximately 7.5 years of follow-up

  11. Percentage of Participants Who Moved on to Stem Cell Transplant

    The percentage of participants who moved on to stem cell transplant was summarized.

    Measured: Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2013 (estimated)
  2. Study start27 Jun 2013
  3. Primary completion28 Oct 2020
  4. Study completion15 Dec 2020

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01889186
Sponsor's protocol ID
M13-982
Other IDs
2012-004027-20
Status last verified
Nov 2021
First submitted
26 Jun 2013
Last updated
16 Dec 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Expanded access
Available

Publications

  • Stilgenbauer S, Eichhorst B, Schetelig J, Coutre S, Seymour JF, Munir T, Puvvada SD, Wendtner CM, Roberts AW, Jurczak W, Mulligan SP, Bottcher S, Mobasher M, Zhu M, Desai M, Chyla B, Verdugo M, Enschede SH, Cerri E, Humerickhouse R, Gordon G, Hallek M, Wierda WG. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. Lancet Oncol. 2016 Jun;17(6):768-778. doi: 10.1016/S1470-2045(16)30019-5. Epub 2016 May 10.

    PubMed 27178240

  • Stilgenbauer S, Tausch E, Roberts AW, Davids MS, Eichhorst B, Hallek M, Hillmen P, Schneider C, Schetelig J, Bottcher S, Kater AP, Jiang Y, Boyer M, Popovic R, Ghanim MT, Moran M, Sinai WJ, Wang X, Mukherjee N, Chyla B, Wierda WG, Seymour JF. Six-year follow-up and subgroup analyses of a phase 2 trial of venetoclax for del(17p) chronic lymphocytic leukemia. Blood Adv. 2024 Apr 23;8(8):1992-2004. doi: 10.1182/bloodadvances.2023011741.

    PubMed 38290108

  • Roberts 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 31023700

  • Stilgenbauer S, Eichhorst B, Schetelig J, Hillmen P, Seymour JF, Coutre S, Jurczak W, Mulligan SP, Schuh A, Assouline S, Wendtner CM, Roberts AW, Davids MS, Bloehdorn J, Munir T, Bottcher S, Zhou L, Salem AH, Desai M, Chyla B, Arzt J, Kim SY, Verdugo M, Gordon G, Hallek M, Wierda WG. Venetoclax for Patients With Chronic Lymphocytic Leukemia With 17p Deletion: Results From the Full Population of a Phase II Pivotal Trial. J Clin Oncol. 2018 Jul 1;36(19):1973-1980. doi: 10.1200/JCO.2017.76.6840. Epub 2018 May 1.

    PubMed 29715056

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-199 (Main Cohort) and ABT-199 (Safety Expansion Cohort) in people with Chronic Lymphocytic Leukemia and 17p Deletion, run by AbbVie at 48 sites in 7 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 17 inclusion and 10 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, United Kingdom, Germany, Australia, France and 2 more countries. 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?

Yes. Results are posted in the registry (first posted 16 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (Main Cohort) (time frame: Up to 36 weeks). The study lists 2 primary outcomes in all. 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 NCT01889186, which also lists 4 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 16 Dec 2021.

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