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Chronic Lymphocytic Leukemia (CLL)Phase 2NCT02966756

A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase 2 study testing Venetoclax in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by AbbVie at 31 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
31 sitesin 4 countries
Study dates
12 Oct 2017to Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Participant must have a diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that meets 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines and the following:
  • Participant must have an indication for treatment according to the 2008 Modified iwCLL NCI-WG Guidelines.
  • SLL participant must have measurable disease (B-lymphocytosis greater than 5 × 10^9/L or an enlarged lymph node(s) (Longest Diameter (LDi) > 1.5 cm at baseline) or hepatomegaly or splenomegaly due to CLL).
  • SLL participant must have presence of lymphadenopathy and absence of cytopenias caused by a clonal marrow infiltrate.
  • Participant must have relapsed or refractory CLL/SLL after receiving at least one prior line of therapy.
  • Participants (in Cohort 1) must have 17p deletion, assessed by a central laboratory.
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  • Participants (in Cohort 2) must meet both of the following:
  • Relapsed/refractory disease to B-Cell Receptor Signaling Pathway Inhibitor (BCRI) treatment;
  • And either of the following: (a) relapsed/refractory disease to chemoimmunotherapy (CIT), or (b) ineligible to receive CIT, defined as having known 17p deletion or TP53 mutation, or Cumulative Illness Rating Scale (CIRS) >6 or calculated creatinine clearance <70 mL/min, or participants in whom the investigator evaluated that the use of CIT was inappropriate.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
  • Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening.
  • No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

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 (AIHA) and idiopathic thrombocytopenic purpura (ITP).
  • Participant has previously received venetoclax or other BCL-2 inhibitors.
  • Participant is known to be positive for Human Immunodeficiency Virus (HIV).
Show all 11Show fewer
  • Participant has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
  • Participant has received any of the following within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of venetoclax, or has not recovered to less than Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
  • Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy or targeted small molecule agents.
  • Investigational therapy, including targeted small molecule agents.
  • Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.

Trial locations and contacts

31 sites in 4 countries.

31 sites in 4 countries

China21 sites

  • Peking University People's Hospital /ID# 156575

    Beijing, Beijing Municipality, 100044

  • Peking Union Medical College Hospital East - Dongdan Campus /ID# 156576

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University /ID# 156532

    Changchun, Jilin, 130021

  • Xiangya Hospital Central South University /ID# 208913

    Changsha, Hunan, 410008

  • West China Hospital, Sichuan University /ID# 156537

    Chengdu, Sichuan, 610041

  • The General Hospital of Western Theater Command PLA /ID# 159145

    Chengdu, Sichuan, 610083

  • Fujian Medical University Union Hospital /ID# 156579

    Fuzhou, Fujian, 350001

  • Guangdong Provincial Peoples Hospital /ID# 160509

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University /ID# 156571

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578

    Hangzhou, Zhejiang, 310003

  • Anhui Provincial Cancer Hospital /ID# 209458

    Hefei, Anhui, 230031

  • Shandong Provincial Hospital /ID# 156574

    Jinan, Shandong, 250021

  • The First Affiliated Hospital of Nanchang University /ID# 159142

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital /ID# 156577

    Nanjing, Jiangsu, 210029

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572

    Shanghai, Shanghai Municipality, 200065

  • The Second Hospital of Hebei Medical University /ID# 159143

    Shijiazhuang, Hebei, 050000

  • The First Affiliated Hospital of Soochow University /ID# 156536

    Suzhou, Jiangsu, 215006

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute & Hospital /ID# 156542

    Tianjin, Tianjin Municipality, 300060

  • Tongji Hospital Tongji Medical College of HUST /ID# 156589

    Wuhan, Hubei, 430030

  • Henan Cancer Hospital /ID# 156573

    Zhengzhou, Henan, 450008

Other trials in China

Taiwan5 sites

  • Changhua Christian Hospital /ID# 202768

    Changhua City, Changhua County, 50006

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765

    Kaohsiung City, 807

  • China Medical University Hospital /ID# 202767

    Taichung, 40447

  • National Taiwan University Hospital /ID# 210733

    Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 203636

    Taoyuan City, 333

Other trials in Taiwan

Australia3 sites

  • Monash Health - Monash Medical Centre - Clayton /ID# 201263

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital /ID# 201261

    Concord, New South Wales, 2139

  • St George Hospital - Kogarah /ID# 206484

    Kogarah, New South Wales, 2217

Other trials in Australia

New Zealand2 sites

  • Christchurch Hospital. /ID# 201650

    Christchurch, Canterbury, 8011

  • North Shore Hospital /ID# 204637

    Takapuna, Auckland, 0622

Other trials in New Zealand

About this study

Official title: A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).

Being tested
Venetoclax
Keywords
Relapsed chronic lymphocytic leukemia (CLL), Refractory chronic lymphocytic leukemia (CLL), 17p deletion, Venetoclax, Leukemia, Lymphoproliferative Disorders, Small Lymphocytic Lymphoma (SLL), Venclexta
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Chromosome 17 deletion, Leukemia, Lymphoproliferative Disorders

What participants receive

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

  • VenetoclaxDrug

    Also called ABT-199, GDC-0199, Venclexta

    Tablet; Oral

Study groups in NCT02966756
Study groupRoleWhat they receive
Cohort 1: VenetoclaxExperimentalParticipants with 17p deletion status will receive various doses of venetoclax once daily (QD).
Receives: Drug: Venetoclax
Cohort 2: VenetoclaxExperimentalParticipants who have failed a B-Cell Receptor Signaling Pathway Inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status will receive various doses of venetoclax once daily (QD).
Receives: Drug: Venetoclax

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR is the proportion of participants with an overall response (complete remission [CR], plus complete remission with incomplete bone marrow recovery [CRi], plus nodular partial remission [nPR], plus partial remission [PR]) per the National Cancer Institute-Working Group (NCI-WG) guidelines as assessed by the Independent Review Committee (IRC).

    Measured: Measured up to 2 years after the last participant has enrolled in the study.

Secondary outcomes (7)

  1. Complete Response Rate (CRR)

    CRR is defined as the proportion of subjects who achieved (CR + CRi) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) NCI-WG criteria.

    Measured: Measured up to 2 years after the last participant has enrolled into the study.

  2. Duration of Overall Response (DOR)

    DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death

    Measured: Measured up to 2 years after the last participant has enrolled into the study.

  3. Progression Free Survival (PFS)

    PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC) or death.

    Measured: Measured up to 5 years after the last participant has enrolled into the study.

  4. Event Free Survival (EFS)

    EFS is 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.

    Measured: Measured up to 5 years after the last participant has enrolled into the study.

  5. Time to Progression (TTP)

    TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC).

    Measured: Measured up to 5 years after the last participant has enrolled into the study.

  6. Time to 50% reduction in absolute lymphocyte count (ALC)

    Time to 50% reduction in ALC is defined as the number of days from the date of first dose to the date when the ALC has reduced to 50% of the baseline value.

    Measured: Measured up to 2 years after the last participant has enrolled into the study.

  7. Overall Survival (OS)

    OS is defined as number of days from the date of first dose to the date of death.

    Measured: Measured up to 5 years after the last participant has enrolled into the study.

Timeline

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

  1. First posted17 Nov 2016 (estimated)
  2. Study start12 Oct 2017
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

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
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02966756
Sponsor's protocol ID
M14-728
Status last verified
Aug 2026
First submitted
15 Nov 2016
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by AbbVie at 31 sites in 4 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 12 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China, Taiwan, Australia, New Zealand. 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?

This study is still under way. Results are not available in the source record yet.

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 (ORR) (time frame: Measured up to 2 years after the last participant has enrolled in the study.). 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 NCT02966756.

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 Aug 2026.

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