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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02910583




Registration number
NCT02910583
Ethics application status
Date submitted
20/09/2016
Date registered
22/09/2016
Date last updated
15/02/2019

Titles & IDs
Public title
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
Scientific title
Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Secondary ID [1] 0 0
PCYC-1142-CA
Universal Trial Number (UTN)
Trial acronym
CAPTIVATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Chronic Lymphocytic 0 0
Lymphoma, Small Lymphocytic 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 - ibrutinib
Treatment: Drugs - placebo to match ibrutinib
Treatment: Drugs - venetoclax

Experimental: MRD Cohort Randomized ibrutinib (blinded) - Subjects will receive 420 mg capsules of single-agent ibrutinib for the first 3 cycles followed by ibrunitib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization. Subjects that are MRD-negative will be randomized to receive ibrutinib 420 mg capsules orally once daily on a continuous schedule until clinical disease progression or unacceptable toxicity

Placebo Comparator: MRD Cohort Randomized Placebo to match ibrutinib (blinded) - Subjects will receive 420 mg capsules of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization. Subjects that are MRD-negative will be randomized to receive matching ibrutinib placebo capsules orally once daily on a continuous schedule until MRD-positive relapse, clinical disease progression or unacceptable toxicity.

Experimental: MRD Cohort Randomized open-label ibrutinib + venetoclax - Subjects will receive 420 mg capsules of single-agent ibrutinib for the first 3 cycles followed by ibrunitib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization. Subjects that are MRD-positive will be randomized to receive ibrutinib 420 mg capsules and venetoclax 400 mg tablets orally once daily on a continuous schedule until clinical disease progression or unacceptable toxicity.

Experimental: MRD Cohort Randomized open-label ibrutinib - Subjects will receive 420 mg capsules of single-agent ibrutinib for the first 3 cycles followed by ibrunitib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization. Subjects that are MRD-positive will be randomized to receive ibrutinib 420 mg capsules orally once daily on a continuous scheduled until clinical disease progression or unacceptable toxicity.

Experimental: Fixed Duration Cohort - Open Label ibrutinib + venetoclax - Subjects will receive 420 mg capsules of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment for 12 cycles (a cycle is defined by 28 days) or until disease progression or unacceptable toxicity.


Treatment: Drugs: ibrutinib
ibrutinib 420mg capsules administered orally once daily

Treatment: Drugs: placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally once daily

Treatment: Drugs: venetoclax
venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MRD-negative response rate
Timepoint [1] 0 0
approximately 40 months
Primary outcome [2] 0 0
Disease free survival
Timepoint [2] 0 0
approximately 40 months
Primary outcome [3] 0 0
Complete Response Rate
Timepoint [3] 0 0
approximately 24 months

Eligibility
Key inclusion criteria
- Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria (Hallek 2008), with active
disease meeting at least 1 IWCLL criteria for requiring treatment.

- Measurable nodal disease by computed tomography (CT)

- Adequate hepatic, and renal function

- Adequate hematologic function

- absolute neutrophil count >750/µL

- platelet count >30,000 /µL

- hemoglobin >8.0 g/dL
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any prior therapy used for treatment of CLL/SLL

- Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk
for TLS

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 0654 - Kogarah
Recruitment hospital [2] 0 0
Site Reference ID/Investigator # 0163 - Bedford Park
Recruitment hospital [3] 0 0
Site Reference ID/Investigator # 0556 - Clayton
Recruitment hospital [4] 0 0
Site Reference ID/Investigator# 0501 - Fitzroy
Recruitment hospital [5] 0 0
Site Reference ID/Investigator #0715 - Frankston
Recruitment hospital [6] 0 0
Site Reference ID/Investigator # 0170 - Heidelberg
Recruitment hospital [7] 0 0
Site Reference ID/Investigator# 0633 - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
- Fitzroy
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Italy
State/province [11] 0 0
Genova
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Italy
State/province [13] 0 0
Modena
Country [14] 0 0
Italy
State/province [14] 0 0
Novara
Country [15] 0 0
Italy
State/province [15] 0 0
Padova
Country [16] 0 0
Italy
State/province [16] 0 0
Piacenza
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
New Zealand
State/province [18] 0 0
Aukland
Country [19] 0 0
New Zealand
State/province [19] 0 0
Christchurch
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Navarra
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Granada
Country [24] 0 0
Spain
State/province [24] 0 0
Salamanca

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pharmacyclics LLC.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen Research & Development, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, 2-cohort Phase 2 study assessing both MRD-guided discontinuation and
fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with
treatment-naïve CLL or SLL
Trial website
https://clinicaltrials.gov/show/NCT02910583
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joi Ninomoto, PharmD
Address 0 0
Pharmacyclics LLC.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications