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Charlottesville, Virginia 22908

  • Chronic Lymphocytic Leukemia

Purpose:

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


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.


Study is Available At:


Original ID:

ACE-CL-006


NCT ID:

NCT02477696


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Acerta Pharma BV


Oversight Authority:

  • Australia: Human Research Ethics Committee
  • Australia: Department of Health and Ageing Therapeutic Goods Administration
  • Belgium: Ethics Committee
  • Belgium: Federal Agency for Medicinal Products and Health Products
  • Denmark: Danish Health and Medicines Authority
  • Denmark: Ethics Committee
  • France: Ethics Committee
  • France: Agence Nationale de Sécurité du Médicament et des produits de santé
  • Hungary: National Institute of Pharmacy
  • Hungary: Scientific and Medical Research Council Ethics Committee
  • Israel: Ethics Commission
  • Italy: Ethics Committee
  • Italy: The Italian Medicines Agency
  • Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
  • Netherlands: Medical Ethics Review Committee (METC)
  • New Zealand: Medsafe
  • New Zealand: Health and Disability Ethics Committees
  • Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • Poland: Ethics Committee
  • Spain: Comité Ético de Investigación Clínica
  • Spain: Agencia Española de Medicamentos y Productos Sanitarios
  • Turkey: Ethics Committee
  • Turkey: Drug and Medical Device Institution
  • United Kingdom: National Health Service
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
  • United States: Food and Drug Administration
  • United States: Institutional Review Board
  • Germany: Federal Institute for Drugs and Medical Devices
  • Germany: Ethics Commission


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

533


Enrollment Type:

Actual


Overall Contact Information

Official Name:Acerta Clinical Trials
Study Director
1-888-292-9613

Study Dates

Start Date:October 2015
Completion Date:March 2021
Completion Type:Anticipated
Primary Completion Date:March 2021
Primary Completion Type:Anticipated
Verification Date:December 2019
Last Changed Date:December 4, 2019
First Received Date:June 12, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall survival in Arm A versus Arm B
Time Frame:36 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of Atrial fibrillation in Arm A versus Arm B
Time Frame:36 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of Richter's transformation in Arm A versus Arm B
Time Frame:36 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of treatment-emergent Grade ≥ 3 infections in Arm A versus Arm B
Time Frame:36 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Progression-free survival in Arm A compared to Arm B
Time Frame:36 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:ACP-196
Arm Name:acalabrutinib
Intervention Type:Drug
Name:ibrutinib
Arm Name:ibrutinib

Study Arms

Study Arm Type:Experimental
Arm Name:acalabrutinib
Description:Acalabrutinib will be orally administered until disease progression or unacceptable toxicity.
Study Arm Type:Active Comparator
Arm Name:ibrutinib
Description:Ibrutinib will be orally administered until disease progression or unacceptable toxicity.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Acerta Pharma BV

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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