Clinical Trials /

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

NCT02717624

Description:

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).

Related Conditions:
  • Mantle Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: ACE-LY-106
  • NCT ID: NCT02717624

Conditions

  • Mantle Cell Lymphoma (MCL)

Interventions

DrugSynonymsArms
Acalabrutinib in combination with BRAcalabrutinib + BRPart 1: Acalabrutinib+BR in RR patients
Acalabrutinib in combination with VRAcalabrutinib + VRPart 2: Acalabrutinib+VR in TN patients

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Part 1: Acalabrutinib+BR in TN patientsExperimentalPart 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients
  • Acalabrutinib in combination with BR
Part 1: Acalabrutinib+BR in RR patientsExperimentalPart 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients
  • Acalabrutinib in combination with BR
Part 2: Acalabrutinib+VR in TN patientsExperimentalPart 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients
  • Acalabrutinib in combination with VR

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Acerta Pharma BV

Trial Keywords

  • Bruton Tyrosine Kinase Inhibitor
  • BTK
  • Mantle Cell Lymphoma
  • MCL
  • Acalabrutinib
  • ACE-LY-106

Last Updated

November 25, 2019