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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02970318




Registration number
NCT02970318
Ethics application status
Date submitted
18/11/2016
Date registered
22/11/2016
Date last updated
16/08/2019

Titles & IDs
Public title
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
Scientific title
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
ACE-CL-309
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 - Acalabrutinib (ACP-196)
Treatment: Drugs - Rituximab
Treatment: Drugs - Idelalisib
Treatment: Drugs - Bendamustine

Experimental: Acalabrutinib (ACP-196) - Acalabrutinib (ACP-196) Monotherapy

Active Comparator: Rituximab Plus Idelalisib or Bendamustine - Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine


Treatment: Drugs: Acalabrutinib (ACP-196)
Acalabrutinib monotherapy

Treatment: Drugs: Rituximab
Rituximab in combination with idelalisib or bendamustine

Treatment: Drugs: Idelalisib
Idelalisib in combination with rituximab

Treatment: Drugs: Bendamustine
Bendamustine in combination with rituximab

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

Outcomes
Primary outcome [1] 0 0
IRC-assessed progression-free survival (PFS) in Arm A compared to Arm B
Timepoint [1] 0 0
48 months
Secondary outcome [1] 0 0
Investigator-assessed progression-free survival (PFS) in Arm A compared to Arm B
Timepoint [1] 0 0
48 months
Secondary outcome [2] 0 0
Investigator and IRC-assessed overall response rate (ORR) in Arm A compared to Arm B
Timepoint [2] 0 0
48 months
Secondary outcome [3] 0 0
Overall survival (OS) in Arm A compared to Arm B
Timepoint [3] 0 0
48 months
Secondary outcome [4] 0 0
Patient reported outcomes (PROs) in Arm A compared to Arm B
Timepoint [4] 0 0
48 months
Secondary outcome [5] 0 0
Investigator and IRC-assessed duration of response (DOR) in Arm A compared to Arm B
Timepoint [5] 0 0
48 months
Secondary outcome [6] 0 0
Time to next treatment (TTNT) in Arm A compared to Arm B
Timepoint [6] 0 0
48 months

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

- ECOG performance status of 0 to 2.

- Received = 1 prior systemic therapies for CLL.

- Diagnosis of CLL - CD-20 positive, and meeting published criteria (Hallek, 2008).

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

- 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 = 50,000 cells/µL or = 30,000 cells/µL in subjects with documented
bone marrow involvement, and without transfusion support 7 days before
assessment.

- AST and ALT = 2.0 x upper limit of normal

- Total bilirubin = 1.5 x ULN.

- Estimated creatinine clearance of = 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 prolymphocytic leukemia or history of, or currently suspected, Richter's
syndrome. Known CNS lymphoma or leukemia.

- Prior exposure to a BCL-2 inhibitor or B-cell receptor inhibitor.

- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.

- 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.

- Major surgery within 30 days of first dose of study drug.

- Prior malignancy, except for adequately treated lentigo maligna melanoma,
non-melanomatous skin cancer, carcinoma in situ or other malignancy treated with no
evidence of active disease > 2 years before Screening and at low risk for recurrence.

- Significant cardiovascular disease within 6 months of screening.

- Known history of infection with HIV, or any uncontrolled active systemic infection.

- Active CMV infection.

- Serologic status reflecting active hepatitis B or C infection.

- History of or ongoing drug-induced pneumonitis.

- Malabsorption syndrome, or other condition that would impair absorption of oral study
medication.

- Received a live virus vaccination within 28 days of first dose of study drug.

- History of stroke or intracranial hemorrhage within 6 months before first dose of
study drug.

- 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,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Gosford
Recruitment hospital [2] 0 0
Research Site - Waratah
Recruitment hospital [3] 0 0
Research Site - Auchenflower
Recruitment hospital [4] 0 0
Research Site - Chermside
Recruitment hospital [5] 0 0
Research Site - South Brisbane
Recruitment hospital [6] 0 0
Research Site - Southport
Recruitment hospital [7] 0 0
Research Site - Adelaide
Recruitment hospital [8] 0 0
Research Site - Woodville South
Recruitment hospital [9] 0 0
Research Site - Hobart
Recruitment hospital [10] 0 0
Research Site - Geelong
Recruitment hospital [11] 0 0
Research Site - Melbourne
Recruitment hospital [12] 0 0
Research Site - Murdoch
Recruitment hospital [13] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- Waratah
Recruitment postcode(s) [3] 0 0
- Auchenflower
Recruitment postcode(s) [4] 0 0
- Chermside
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
- Southport
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
- Woodville South
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
- Geelong
Recruitment postcode(s) [11] 0 0
- Melbourne
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment postcode(s) [13] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Nebraska
Country [3] 0 0
Austria
State/province [3] 0 0
Upper Austria
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Austria
State/province [5] 0 0
Salzburg
Country [6] 0 0
Belgium
State/province [6] 0 0
Antwerpen
Country [7] 0 0
Belgium
State/province [7] 0 0
West-vlaanderen
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Yvoir
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Pleven
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Plovdiv
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Vratsa
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
New Brunswick
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Croatia
State/province [17] 0 0
Zagreb
Country [18] 0 0
Czechia
State/province [18] 0 0
Jihormoravsky KRAJ
Country [19] 0 0
Czechia
State/province [19] 0 0
Olomoucky
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha
Country [21] 0 0
Czechia
State/province [21] 0 0
Severomoravsky KRAJ
Country [22] 0 0
Czechia
State/province [22] 0 0
Vychodocesky KRAJ
Country [23] 0 0
Czechia
State/province [23] 0 0
Plzen - Lochotin
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France
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Aquitaine
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France
State/province [25] 0 0
Bretagne
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France
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Ile-de-france
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France
State/province [27] 0 0
PAYS DE LA Loire
Country [28] 0 0
France
State/province [28] 0 0
Provence Alpes COTE D'azur
Country [29] 0 0
Germany
State/province [29] 0 0
Baden-wuerttemberg
Country [30] 0 0
Germany
State/province [30] 0 0
Bayern
Country [31] 0 0
Hong Kong
State/province [31] 0 0
Hong Kong
Country [32] 0 0
Hungary
State/province [32] 0 0
Bekes
Country [33] 0 0
Hungary
State/province [33] 0 0
Hajdu-bihar
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Israel
State/province [35] 0 0
Ashqelon
Country [36] 0 0
Israel
State/province [36] 0 0
Haifa
Country [37] 0 0
Israel
State/province [37] 0 0
Jerusalem
Country [38] 0 0
Italy
State/province [38] 0 0
Forli-cesena
Country [39] 0 0
Italy
State/province [39] 0 0
Lombardia
Country [40] 0 0
Italy
State/province [40] 0 0
Pordenone
Country [41] 0 0
Italy
State/province [41] 0 0
Brescia
Country [42] 0 0
Italy
State/province [42] 0 0
Genova
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
State/province [44] 0 0
Modena
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Korea, Republic of
State/province [45] 0 0
Chungcheongnam-do
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Gyeonggi-do
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Incheon
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Korea, Republic of
State/province [48] 0 0
Seoul
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Korea, Republic of
State/province [49] 0 0
Ulsan
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New Zealand
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Manawatu-wanganui
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New Zealand
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Christchurch
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Poland
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Kujawsko-pomorskie
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Poland
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Lodzkie
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Lubelskie
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Malopolskie
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Podkarpackie
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Podlaskie
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Pomorskie
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Russian Federation
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Krasnodar
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Russian Federation
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Ryazanr
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Russian Federation
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Saint Petersburg
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Russian Federation
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Sverdlovsk
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Yaroslavlr
Country [64] 0 0
Russian Federation
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Penza
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Russian Federation
State/province [65] 0 0
Tula
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Russian Federation
State/province [66] 0 0
Volgograd
Country [67] 0 0
Singapore
State/province [67] 0 0
Singapore
Country [68] 0 0
Slovakia
State/province [68] 0 0
Bratislava
Country [69] 0 0
Slovakia
State/province [69] 0 0
KoŇ°ice
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
State/province [72] 0 0
Salamanca
Country [73] 0 0
Spain
State/province [73] 0 0
Santander
Country [74] 0 0
Spain
State/province [74] 0 0
Valencia
Country [75] 0 0
Sweden
State/province [75] 0 0
Västra Götaland
Country [76] 0 0
Sweden
State/province [76] 0 0
Luleå
Country [77] 0 0
Sweden
State/province [77] 0 0
Stockholm
Country [78] 0 0
Taiwan
State/province [78] 0 0
Hualien City
Country [79] 0 0
Ukraine
State/province [79] 0 0
Kiev
Country [80] 0 0
Ukraine
State/province [80] 0 0
Cherkasy
Country [81] 0 0
Ukraine
State/province [81] 0 0
Dnipropetrovsk
Country [82] 0 0
Ukraine
State/province [82] 0 0
Ivano-Frankivsk
Country [83] 0 0
Ukraine
State/province [83] 0 0
Khmelnytskyi
Country [84] 0 0
Ukraine
State/province [84] 0 0
Zhytomyr
Country [85] 0 0
United Kingdom
State/province [85] 0 0
England

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 the efficacy of acalabrutinib compared with rituximab in
combination with idelalisib or bendamustine in previously treated subjects with chronic
lymphocytic leukemia (CLL).
Trial website
https://clinicaltrials.gov/show/NCT02970318
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Acerta Clinical Trials
Address 0 0
1-888-292-9613; acertamc@dlss.com
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