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A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

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ClinicalTrials.gov Identifier: NCT02970318
Recruitment Status : Active, not recruiting
First Posted : November 22, 2016
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

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).

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Acalabrutinib (ACP-196) Drug: Rituximab Drug: Idelalisib Drug: Bendamustine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 28, 2017
Actual Primary Completion Date : January 15, 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Acalabrutinib (ACP-196)
Acalabrutinib (ACP-196) Monotherapy
Drug: Acalabrutinib (ACP-196)
Acalabrutinib monotherapy

Active Comparator: Rituximab Plus Idelalisib or Bendamustine
Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine
Drug: Rituximab
Rituximab in combination with idelalisib or bendamustine

Drug: Idelalisib
Idelalisib in combination with rituximab

Drug: Bendamustine
Bendamustine in combination with rituximab




Primary Outcome Measures :
  1. IRC-assessed progression-free survival (PFS) in Arm A compared to Arm B [ Time Frame: 48 months ]

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

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.

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): NCT02970318


  Show 108 Study Locations
Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02970318     History of Changes
Other Study ID Numbers: ACE-CL-309
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acerta Pharma BV:
CLL
BTK
Bruton Tyrosine Kinase
acalabrutinib
ACP-196
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
Rituximab
Bendamustine Hydrochloride
Idelalisib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors