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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02966756




Registration number
NCT02966756
Ethics application status
Date submitted
15/11/2016
Date registered
17/11/2016

Titles & IDs
Public title
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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
Secondary ID [1] 0 0
M14-728
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia (CLL) 0 0
Small Lymphocytic Lymphoma (SLL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
Measured up to 2 years after the last participant has enrolled in the study.
Secondary outcome [1] 0 0
Complete Response Rate (CRR)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Measured up to 2 years after the last participant has enrolled into the study.
Secondary outcome [2] 0 0
Duration of Overall Response (DOR)
Assessment method [2] 0 0
DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death
Timepoint [2] 0 0
Measured up to 2 years after the last participant has enrolled into the study.
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Measured up to 5 years after the last participant has enrolled into the study.
Secondary outcome [4] 0 0
Event Free Survival (EFS)
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Measured up to 5 years after the last participant has enrolled into the study.
Secondary outcome [5] 0 0
Time to Progression (TTP)
Assessment method [5] 0 0
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).
Timepoint [5] 0 0
Measured up to 5 years after the last participant has enrolled into the study.
Secondary outcome [6] 0 0
Time to 50% reduction in absolute lymphocyte count (ALC)
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Measured up to 2 years after the last participant has enrolled into the study.
Secondary outcome [7] 0 0
Overall Survival (OS)
Assessment method [7] 0 0
OS is defined as number of days from the date of first dose to the date of death.
Timepoint [7] 0 0
Measured up to 5 years after the last participant has enrolled into the study.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2029
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital /ID# 201261 - Concord
Recruitment hospital [2] 0 0
St George Hospital /ID# 206484 - Kogarah
Recruitment hospital [3] 0 0
Monash Medical Centre /ID# 201263 - Clayton
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Anhui
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
China
State/province [3] 0 0
Fujian
Country [4] 0 0
China
State/province [4] 0 0
Guangdong
Country [5] 0 0
China
State/province [5] 0 0
Hebei
Country [6] 0 0
China
State/province [6] 0 0
Henan
Country [7] 0 0
China
State/province [7] 0 0
Hubei
Country [8] 0 0
China
State/province [8] 0 0
Hunan
Country [9] 0 0
China
State/province [9] 0 0
Jiangsu
Country [10] 0 0
China
State/province [10] 0 0
Jiangxi
Country [11] 0 0
China
State/province [11] 0 0
Jilin
Country [12] 0 0
China
State/province [12] 0 0
Shandong
Country [13] 0 0
China
State/province [13] 0 0
Shanghai
Country [14] 0 0
China
State/province [14] 0 0
Sichuan
Country [15] 0 0
China
State/province [15] 0 0
Tianjin
Country [16] 0 0
China
State/province [16] 0 0
Zhejiang
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
New Zealand
State/province [18] 0 0
Canterbury
Country [19] 0 0
Taiwan
State/province [19] 0 0
Changhua City, Changhua County
Country [20] 0 0
Taiwan
State/province [20] 0 0
Kaohsiung
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taichung
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei City
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02966756