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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02477696




Registration number
NCT02477696
Ethics application status
Date submitted
12/06/2015
Date registered
23/06/2015
Date last updated
17/04/2019

Titles & IDs
Public title
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk CLL
Scientific title
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
ACE-CL-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
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 - ACP-196
Treatment: Drugs - ibrutinib

Experimental: acalabrutinib - Acalabrutinib will be orally administered until disease progression or unacceptable toxicity.

Active Comparator: ibrutinib - Ibrutinib will be orally administered until disease progression or unacceptable toxicity.


Treatment: Drugs: ACP-196


Treatment: Drugs: ibrutinib


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

Outcomes
Primary outcome [1] 0 0
Progression-free survival in Arm A compared to Arm B
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Incidence of treatment-emergent Grade = 3 infections in Arm A versus Arm B
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Incidence of Richter's transformation in Arm A versus Arm B
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Incidence of Atrial fibrillation in Arm A versus Arm B
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Overall survival in Arm A versus Arm B
Timepoint [4] 0 0
36 months

Eligibility
Key inclusion criteria
- Men and women = 18 years of age.

- ECOG performance status of 0 to 2.

- Diagnosis of CLL.

- Must have = 1 of the following high-risk prognostic factors:

- Presence of 17p del by central laboratory.

- Presence of 11q del by central laboratory.

- Active disease meeting = 1 of the following IWCLL 2008 criteria for requiring
treatment

- Must have received = 1 prior therapies for CLL.

- Meet the following laboratory parameters:

- ANC = 750 cells/µL or = 500 cells/µL in subjects with documented bone marrow
involvement, and independent of growth factor support 7 days before assessment.

- Platelet count = 30,000 cells/µL without transfusion support 7 days before
assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.

- Serum AST/SGOT and ALT/SGPT = 3.0 x ULN.

- Total bilirubin = 1.5 x ULN.

- Estimated creatinine clearance = 30 mL/min.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known CNS lymphoma or leukemia.

- Known prolymphocytic leukemia or history of, or currently suspected, Richter's
syndrome.

- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.

- Prior exposure to ibrutinib or to a BCR inhibitor or a BCL-2 inhibitor.

- Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or
investigational drug within 30 days before first dose of study drug.

- Prior radio- or toxin-conjugated antibody therapy.

- Prior allogeneic stem cell or autologous transplant.

- Major surgery within 4 weeks before first dose of study drug.

- Prior malignancy, except for adequately treated lentigo maligna melanoma,
non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated
with no evidence of active disease > 3 years before Screening and at low risk for
recurrence.

- Significant cardiovascular disease within 6 months of screening.

- Known history of infection with HIV.

- History of stroke or intracranial hemorrhage within 6 months before randomization.

- History of bleeding diathesis.

- Requires or receiving anticoagulation with warfarin or equivalent vitamin K
antagonists within 7 days of first dose of study drug.

- Requires treatment with a strong CYP3A inhibitor/inducer.

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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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,VIC
Recruitment hospital [1] 0 0
- Darlinghurst
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- St Leonards
Recruitment hospital [3] 0 0
- Waratah
Recruitment hospital [4] 0 0
- Wollongong
Recruitment hospital [5] 0 0
- Frankston
Recruitment hospital [6] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment outside Australia
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Acerta Pharma BV
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously
treated chronic lymphocytic leukemia.
Trial website
https://clinicaltrials.gov/show/NCT02477696
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Acerta Clinical Trials
Address 0 0
1-888-292-9613
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