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Elevate CLL R/R: Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia

This study is currently recruiting participants.
Verified May 2017 by Acerta Pharma BV
Sponsor:
ClinicalTrials.gov Identifier:
NCT02477696
First Posted: June 23, 2015
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Acerta Pharma BV
  Purpose
This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia.

Condition Intervention Phase
Chronic Lymphocytic Leukemia Drug: ACP-196 Drug: ibrutinib Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Acerta Pharma BV:

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

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

Estimated Enrollment: 500
Study Start Date: June 2015
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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


Contacts
Contact: Acerta Pharma 1-888-292-9613

  Show 160 Study Locations
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Priti Patel, MD Acerta Pharma BV
  More Information

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02477696     History of Changes
Other Study ID Numbers: ACE-CL-006
First Submitted: June 12, 2015
First Posted: June 23, 2015
Last Update Posted: May 31, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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