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Trial record 1 of 1 for:    NCT02970318
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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

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE November 22, 2016
Last Update Posted Date August 16, 2019
Actual Study Start Date  ICMJE February 28, 2017
Actual Primary Completion Date January 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
IRC-assessed progression-free survival (PFS) in Arm A compared to Arm B [ Time Frame: 48 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
Progression-free survival (PFS) in Arm A compared to Arm B [ Time Frame: 48 months ]
Change History Complete list of historical versions of study NCT02970318 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
  • Investigator-assessed progression-free survival (PFS) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Investigator and IRC-assessed overall response rate (ORR) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Overall survival (OS) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Patient reported outcomes (PROs) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Investigator and IRC-assessed duration of response (DOR) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Time to next treatment (TTNT) in Arm A compared to Arm B [ Time Frame: 48 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
  • IRC-assessed overall response rate (ORR) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Time to next treatment (TTNT) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Overall survival (OS) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Duration of response (DOR) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Patient reported outcomes (PROs) in Arm A compared to Arm B [ Time Frame: 48 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: Acalabrutinib (ACP-196)
    Acalabrutinib monotherapy
  • Drug: Rituximab
    Rituximab in combination with idelalisib or bendamustine
  • Drug: Idelalisib
    Idelalisib in combination with rituximab
  • Drug: Bendamustine
    Bendamustine in combination with rituximab
Study Arms  ICMJE
  • Experimental: Acalabrutinib (ACP-196)
    Acalabrutinib (ACP-196) Monotherapy
    Intervention: Drug: Acalabrutinib (ACP-196)
  • Active Comparator: Rituximab Plus Idelalisib or Bendamustine
    Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine
    Interventions:
    • Drug: Rituximab
    • Drug: Idelalisib
    • Drug: Bendamustine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2016)
306
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Actual Primary Completion Date January 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Croatia,   Czechia,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   New Zealand,   Poland,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970318
Other Study ID Numbers  ICMJE ACE-CL-309
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acerta Pharma BV
Study Sponsor  ICMJE Acerta Pharma BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
PRS Account Acerta Pharma BV
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP