Trial record 1 of 1 for:
ACE-CL-006
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk CLL
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| ClinicalTrials.gov Identifier: NCT02477696 |
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Recruitment Status :
Active, not recruiting
First Posted : June 23, 2015
Last Update Posted : February 16, 2021
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Sponsor:
Acerta Pharma BV
Information provided by (Responsible Party):
Acerta Pharma BV
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 533 participants |
| Allocation: | N/A |
| 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 |
| Actual Study Start Date : | September 17, 2015 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | June 30, 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: ACP-196
acalabrutinib 100 mg BID (Arm A; N=250)
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Drug: ACP-196
acalabrutinib 100 mg BID (Arm A; N=250) |
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Active Comparator: ibrutinib
ibrutinib 420 mg QD (Arm B; N=250)
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Drug: ibrutinib
ibrutinib 420 mg QD (Arm B; N=250) |
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 ]
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| Ages Eligible for Study: | Child, 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.
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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.
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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
Locations
Show 132 study locations
Sponsors and Collaborators
Acerta Pharma BV
Investigators
| Study Director: | Acerta Clinical Trials | 1-888-292-9613 |
| Responsible Party: | Acerta Pharma BV |
| ClinicalTrials.gov Identifier: | NCT02477696 |
| Other Study ID Numbers: |
ACE-CL-006 |
| First Posted: | June 23, 2015 Key Record Dates |
| Last Update Posted: | February 16, 2021 |
| Last Verified: | January 2021 |
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 |