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Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk CLL

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ClinicalTrials.gov Identifier: NCT02477696
Recruitment Status : Active, not recruiting
First Posted : June 23, 2015
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: ACP-196 Drug: ibrutinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 533 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: acalabrutinib
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity.
Drug: ACP-196
Active Comparator: ibrutinib
Ibrutinib will be orally administered until disease progression or unacceptable toxicity.
Drug: ibrutinib



Primary Outcome Measures :
  1. Progression-free survival in Arm A compared to Arm B [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Incidence of treatment-emergent Grade ≥ 3 infections in Arm A versus Arm B [ Time Frame: 36 months ]
  2. Incidence of Richter's transformation in Arm A versus Arm B [ Time Frame: 36 months ]
  3. Incidence of Atrial fibrillation in Arm A versus Arm B [ Time Frame: 36 months ]
  4. Overall survival in Arm A versus Arm B [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477696


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Locations
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United States, Arizona
Phoenix, Arizona, United States, 85054
United States, Arkansas
Hot Springs, Arkansas, United States, 71913
United States, California
Anaheim, California, United States, 92801
Berkeley, California, United States, 94704
Duarte, California, United States, 91010
La Jolla, California, United States, 92093
Los Angeles, California, United States, 90017
Los Angeles, California, United States, 90095
Orange, California, United States, 92868
Palo Alto, California, United States, 94305
Santa Rosa, California, United States, 95403
United States, Florida
Jacksonville, Florida, United States, 32224
Tampa, Florida, United States, 33612
United States, Georgia
Athens, Georgia, United States, 30607
United States, Illinois
Harvey, Illinois, United States, 60426
Peoria, Illinois, United States, 61615
United States, Iowa
Cedar Rapids, Iowa, United States, 52403
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Mount Sterling, Kentucky, United States, 40353
United States, Maryland
Silver Spring, Maryland, United States, 20910
United States, Minnesota
Rochester, Minnesota, United States, 55905
Saint Cloud, Minnesota, United States, 56303
Saint Louis Park, Minnesota, United States, 55426
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings, Montana, United States, 59102
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Flemington, New Jersey, United States, 08822
Hackensack, New Jersey, United States, 07601
United States, New York
Lake Success, New York, United States, 11042
New Hyde Park, New York, United States, 11040
New York, New York, United States, 10029
New York, New York, United States, 10032
United States, North Carolina
Durham, North Carolina, United States, 27705
United States, Ohio
Canton, Ohio, United States, 44718
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Houston, Texas, United States, 77030
Lubbock, Texas, United States, 79415
Round Rock, Texas, United States, 78665
United States, Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Everett, Washington, United States, 98201
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99208
Tacoma, Washington, United States, 98405
Australia, New South Wales
Darlinghurst, New South Wales, Australia, 2010
St Leonards, New South Wales, Australia, 2065
Waratah, New South Wales, Australia, 2298
Wollongong, New South Wales, Australia, 2500
Australia, Victoria
Frankston, Victoria, Australia, 3199
Melbourne, Victoria, Australia, 3000
Belgium
Yvoir, Namur, Belgium, 5530
Gent, Oost-Vlaanderen, Belgium, 9000
Leuven, Vlaams Brabant, Belgium, 3000
Brugge, West-Vlaanderen, Belgium, 8000
Ieper, West-Vlaanderen, Belgium, 8900
Brussels, Belgium, 1200
Liège, Belgium, 4000
Denmark
Aalborg, Nordjylland, Denmark, DK-9000
Roskilde, Denmark, DK-4000
France
Rennes, Ille-et-Vilaine, France, 95033
Pierre-Bénite, Rhône, France, 69495
Rouen, Seine-Maritime, France, 76038
Bobigny, Seine-Saint-Denis, France, 93009
Créteil, France, 94010
Toulouse, France, 31059
Germany
Ulm, Baden-Württemberg, Germany, 89081
Erlangen, Bayern, Germany, 91052
München, Bayern, Germany, 80804
München, Bayern, Germany, 81241
Bad Saarow, Brandenburg, Germany, 15526
Hungary
Budapest, Hungary, 1083
Budapest, Hungary, 1122
Debrecen, Hungary, 4032
Kaposvár, Hungary, 7400
Israel
Haifa, Israel, 31096
Haifa, Israel, 33394
Haifa, Israel, 34362
Jerusalem, Israel, 91031
Nahariya, Israel, 22100
Petaẖ Tiqwa, Israel, 49100
Ramat Gan, Israel, 52621
Tiberias, Israel, 15208
Italy
Bologna, Emilia-Romagna, Italy, 40138
Modena, Emilia-Romagna, Italy, 41100
Cona, Ferrara, Italy, 44124
Brescia, Lombardia, Italy, 25123
Milano, Lombardia, Italy, 20132
Rozzano, Lombardia, Italy, 20089
Cagliari, Italy, 09121
Firenze, Italy, 50139
Meldola, Italy, 47014
Milano, Italy, 20162
Ravenna, Italy, 48100
Rome, Italy, 00168
Netherlands
Assen, Drenthe, Netherlands, 9401 RK
Almere, Flevoland, Netherlands, 1315 RA
Apeldoorn, Gelderland, Netherlands, 7334 DZ
Ede, Gelderland, Netherlands, 6716 RP
Maastricht, Limburg, Netherlands, 6229 HX
Sittard, Limburg, Netherlands, 6162 BG
Breda, Noord-Brabant, Netherlands, 4818 CK
Veldhoven, Noord-Brabant, Netherlands, 5504 DB
Amsterdam, Noord-Holland, Netherlands, 1066 EC
Amsterdam, Noord-Holland, Netherlands, 1091 AC
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Hilversum, Noord-Holland, Netherlands, 1213 XZ
Hoofddorp, Noord-Holland, Netherlands, 2134 TM
Delft, Zuid-Holland, Netherlands, 2625 AD
Dordrecht, Zuid-Holland, Netherlands, 3318 AT
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Rotterdam, Zuid-Holland, Netherlands, 3075 EA
Rotterdam, Zuid-Holland, Netherlands, 3083 AN
Groningen, Netherlands, 9713 GZ
The Hague, Netherlands, 2501 CK
Utrecht, Netherlands, 3584 CX
Zutphen, Netherlands, 7207 AE
New Zealand
Takapuna, Auckland, New Zealand, 0622
Tauranga, Bay Of Plenty, New Zealand, 3143
Poland
Wrocław, Dolnoslaskie, Poland, 50-556
Łódź, Lódzkie, Poland, 93-510
Kraków, Malopolskie, Poland, 30-510
Gdańsk, Pomorskie, Poland, 80-219
Gdynia, Pomorskie, Poland, 81-519
Słupsk, Pomorskie, Poland, 76-200
Olsztyn, Warminsko-mazurskie, Poland, 10-228
Bydgoszcz, Poland, 85-168
Opole, Poland, 45-061
Spain
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Santander, Cantabria, Spain, 39008
Majadahonda, Madrid, Spain, 28222
Barcelona, Spain, 08041
Madrid, Spain, 28006
Madrid, Spain, 28009
Madrid, Spain, 28031
Madrid, Spain, 28041
Murcia, Spain, 30008
Turkey
Ankara, Turkey, 06500
Ankara, Turkey, 06590
İstanbul, Turkey, 34365
İstanbul, Turkey, 34390
İzmir, Turkey, 35040
İzmir, Turkey, 35340
Kayseri, Turkey, 38039
United Kingdom
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Plymouth, Devon, United Kingdom, PL6 8DH
Bournemouth, Dorset, United Kingdom, BH7 7DW
Southampton, Hampshire, United Kingdom, SO16 6YD
Leicester, Leichestershire, United Kingdom, LE1 5WW
Liverpool, Merseyside, United Kingdom, L7 8XP
Cottingham, Northamptonshire, United Kingdom, HU16 5JQ
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Sutton, Surrey, United Kingdom, SM2 5PT
Leeds, Yorkshire, United Kingdom, LS9 7TF
Birmingham, United Kingdom, B9 5SS
Cardiff, United Kingdom, CF14 4XW
London, United Kingdom, EC1A 7BE
London, United Kingdom, SE5 9RS
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02477696     History of Changes
Other Study ID Numbers: ACE-CL-006
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell