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.
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
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- 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
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).
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- 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
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
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
New Zealand2 sites
Christchurch Hospital. /ID# 201650
Christchurch, Canterbury, 8011
North Shore Hospital /ID# 204637
Takapuna, Auckland, 0622
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 group | Role | What they receive |
|---|---|---|
| Cohort 1: Venetoclax | Experimental | Participants with 17p deletion status will receive various doses of venetoclax once daily (QD). Receives: Drug: Venetoclax |
| Cohort 2: Venetoclax | Experimental | Participants 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.
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)
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.
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.
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.
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.
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.
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.
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.
- First posted17 Nov 2016 (estimated)
- Study start12 Oct 2017
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
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.