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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02966756
Registration number
NCT02966756
Ethics application status
Date submitted
15/11/2016
Date registered
17/11/2016
Date last updated
12/03/2024
Titles & IDs
Public title
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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Scientific title
A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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Secondary ID [1]
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M14-728
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia (CLL)
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Small Lymphocytic Lymphoma (SLL)
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Venetoclax
Experimental: Cohort 1: Venetoclax - Participants with 17p deletion status will receive various doses of venetoclax once daily (QD).
Experimental: Cohort 2: Venetoclax - 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).
Treatment: Drugs: Venetoclax
Tablet; Oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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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).
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Timepoint [1]
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Measured up to 2 years after the last participant has enrolled in the study.
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Secondary outcome [1]
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Complete Response Rate (CRR)
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Assessment method [1]
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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.
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Timepoint [1]
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Measured up to 2 years after the last participant has enrolled into the study.
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Secondary outcome [2]
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Duration of Overall Response (DOR)
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Assessment method [2]
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DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death
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Timepoint [2]
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Measured up to 2 years after the last participant has enrolled into the study.
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Secondary outcome [3]
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Progression Free Survival (PFS)
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Assessment method [3]
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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.
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Timepoint [3]
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Measured up to 5 years after the last participant has enrolled into the study.
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Secondary outcome [4]
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Event Free Survival (EFS)
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Assessment method [4]
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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.
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Timepoint [4]
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Measured up to 5 years after the last participant has enrolled into the study.
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Secondary outcome [5]
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Time to Progression (TTP)
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Assessment method [5]
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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).
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Timepoint [5]
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Measured up to 5 years after the last participant has enrolled into the study.
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Secondary outcome [6]
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Time to 50% reduction in absolute lymphocyte count (ALC)
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Assessment method [6]
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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.
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Timepoint [6]
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Measured up to 2 years after the last participant has enrolled into the study.
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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OS is defined as number of days from the date of first dose to the date of death.
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Timepoint [7]
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Measured up to 5 years after the last participant has enrolled into the study.
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Eligibility
Key inclusion criteria
- 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.
- 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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.
- Participant is known to be positive for Human Immunodeficiency Virus (HIV).
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/10/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/05/2029
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Actual
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Sample size
Target
110
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital /ID# 201261 - Concord
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Recruitment hospital [2]
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St George Hospital /ID# 206484 - Kogarah
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Recruitment hospital [3]
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Monash Medical Centre /ID# 201263 - Clayton
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Anhui
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Country [2]
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China
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State/province [2]
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Beijing
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Country [3]
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China
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State/province [3]
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Fujian
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Country [4]
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China
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State/province [4]
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Guangdong
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Country [5]
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China
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State/province [5]
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Hebei
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Country [6]
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China
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State/province [6]
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Henan
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Country [7]
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China
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State/province [7]
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Hubei
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Country [8]
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China
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State/province [8]
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Hunan
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Country [9]
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China
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State/province [9]
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Jiangsu
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Country [10]
0
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China
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State/province [10]
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Jiangxi
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Country [11]
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China
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State/province [11]
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Jilin
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Country [12]
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China
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State/province [12]
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Shandong
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Country [13]
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China
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State/province [13]
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Shanghai
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Country [14]
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China
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State/province [14]
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Sichuan
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Country [15]
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China
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State/province [15]
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Tianjin
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Country [16]
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China
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State/province [16]
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Zhejiang
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Country [17]
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New Zealand
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State/province [17]
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Auckland
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Country [18]
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New Zealand
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State/province [18]
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Canterbury
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Country [19]
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Taiwan
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State/province [19]
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Changhua City, Changhua County
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Country [20]
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Taiwan
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State/province [20]
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Kaohsiung
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Country [21]
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Taiwan
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State/province [21]
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Taichung
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Country [22]
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Taiwan
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State/province [22]
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Taipei City
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Country [23]
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Taiwan
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State/province [23]
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Taoyuan City
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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) therapy and who have also failed, or were
unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02966756
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02966756
Download to PDF