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A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT02735876
Recruitment Status : Withdrawn
First Posted : April 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE April 8, 2016
First Posted Date  ICMJE April 13, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
Progression-free survival (PFS) assessed by Independent Review Committee (IRC) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). The primary analysis is a comparison of progression-free survival (PFS) between Arm 1 and Arm 2. [ Time Frame: 48 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
Progression-free survival (PFS) assessed by Independent Review Committee (IRC) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). The primary analysis is a comparison of PFS between Arm 1 and Arm 2. [ Time Frame: 48 months ]
Change History Complete list of historical versions of study NCT02735876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
  • Investigator-assessed progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). [ Time Frame: 48 months ]
  • Investigator-assessed overall response rate (ORR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). [ Time Frame: 48 months ]
  • Overall survival (OS). [ Time Frame: 48 months ]
  • IRC-assessed duration of response (DOR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). [ Time Frame: 48 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • Investigator-assessed PFS per the Lugano Classification for NHL. [ Time Frame: 48 months ]
  • Investigator-assessed overall response rate (ORR) per the Lugano Classification for NHL. [ Time Frame: 48 months ]
  • Overall survival (OS). [ Time Frame: 48 months ]
  • IRC-assessed duration of response (DOR) per the Lugano Classification for NHL [ Time Frame: 48 months ]
Current Other Pre-specified Outcome Measures
 (submitted: April 12, 2016)
Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events (AEs) leading to treatment discontinuation. [ Time Frame: 48 months ]
Original Other Pre-specified Outcome Measures
 (submitted: April 8, 2016)
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation. [ Time Frame: 48 months ]
 
Descriptive Information
Brief Title  ICMJE A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Official Title  ICMJE A Randomized, Multicenter, Open Label, Phase 3 Study of Acalabrutinib (ACP-196) in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib Alone in Subjects With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL)
Brief Summary This study is evaluating the efficacy of acalabrutinib in combination with rituximab (Arm 1) versus ibrutinib (Arm 2) versus acalabrutinib (Arm 3) for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mantle Cell Lymphoma
Intervention  ICMJE
  • Drug: acalabrutinib
  • Drug: ibrutinib
  • Drug: rituximab
Study Arms  ICMJE
  • Experimental: acalabrutinib plus rituximab
    Acalabrutinib will be orally administered until disease progression or unacceptable toxicity. Rituximab IV infusions will be administered weekly for 4 weeks and on Day 1 of Cycle 3 through 8, and thereafter every other cycle for less than or equal to two years (approximately 200 subjects).
    Interventions:
    • Drug: acalabrutinib
    • Drug: rituximab
  • Active Comparator: ibrutinib
    Ibrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 200 subjects).
    Intervention: Drug: ibrutinib
  • Experimental: acalabrutinib
    Acalabrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 50 subjects).
    Intervention: Drug: acalabrutinib
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 12, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2016)
450
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • Pathologically confirmed mantle cell lymphoma (MCL).
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Agreement to use highly effective forms of contraception during the study and for 90 days after the last dose of acalabrutinib or ibrutinib or 12 months after the last dose of rituximab (whichever is longest).
  • Disease that has relapsed, or been refractory to, ≥ 1 prior treatment regimen for mantle cell lymphoma (MCL).
  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Exclusion Criteria:

  • Any history of central nervous system (CNS) lymphoma or leptomeningeal disease.
  • Prior exposure to ibrutinib or to a B-cell receptor (BCR) inhibitor.
  • Significant cardiovascular disease.
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
  • Uncontrolled active systemic fungal, bacterial, viral, or other infection.
  • Known history of infection with human immunodeficiency virus (HIV).
  • History of hepatitis B (HBV) infection or active infection with hepatitis C (HCV).
  • Breastfeeding or pregnant.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02735876
Other Study ID Numbers  ICMJE ACE-LY-309
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Acerta Pharma BV
Study Sponsor  ICMJE Acerta Pharma BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sandeep Inamdar, MBBS Acerta Pharma, LLC
PRS Account Acerta Pharma BV
Verification Date April 2016

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