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Trial record 21 of 32 for:    Acerta Pharma | ( Map: United States )

A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL

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ClinicalTrials.gov Identifier: NCT02717624
Recruitment Status : Recruiting
First Posted : March 24, 2016
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE February 24, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date March 28, 2019
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date May 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03 [ Time Frame: From first dose of study drug to within 30 days of last dose of study drug ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02717624 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
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 in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
Official Title  ICMJE A Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination With Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects With Mantle Cell Lymphoma
Brief Summary This is a multicenter, open-label Phase 1b study to assess the safety and efficacy of acalabrutinib when administered concomitantly with bendamustine and rituximab in subjects with treatment naive or relapse refractory mantle cell lymphoma (Part 1), or when administered concomitantly with venetoclax and rituximab in subjects with treatment naive mantle cell lymphoma (Part 2).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mantle Cell Lymphoma (MCL)
Intervention  ICMJE
  • Drug: Acalabrutinib in combination with BR
    Other Name: Acalabrutinib + BR
  • Drug: Acalabrutinib in combination with VR
    Other Name: Acalabrutinib + VR
Study Arms  ICMJE
  • Experimental: Part 1: Acalabrutinib+BR in TN patients
    Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients
    Intervention: Drug: Acalabrutinib in combination with BR
  • Experimental: Part 1: Acalabrutinib+BR in RR patients
    Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients
    Intervention: Drug: Acalabrutinib in combination with BR
  • Experimental: Part 2: Acalabrutinib+VR in TN patients
    Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients
    Intervention: Drug: Acalabrutinib in combination with VR
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2016)
48
Estimated Study Completion Date  ICMJE May 2026
Estimated Primary Completion Date May 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • Pathologically confirmed MCL.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Agreement to use highly effective forms of contraception during the study and for 2 days after the last dose of acalabrutinib, 30 days after the last dose of venetoclax, or 12 months after the last dose of rituximab, whichever is longest.
  • Treatment Naive MCL patients requiring treatment with no exposure to prior therapies.

Exclusion Criteria:

  • Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, 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 (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug
  • Breastfeeding or pregnant
  • Concurrent participation in another therapeutic clinical trial.
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: Acerta Clinical Trials 1-888-292-9613 acertamc@dlss.com
Listed Location Countries  ICMJE United States,   Italy,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02717624
Other Study ID Numbers  ICMJE ACE-LY-106
Has Data Monitoring Committee No
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 March 2019

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