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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 : Active, not recruiting
First Posted : March 24, 2016
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

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).

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma (MCL) Drug: Acalabrutinib in combination with BR Drug: Acalabrutinib in combination with VR Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026


Arm Intervention/treatment
Experimental: Part 1: Acalabrutinib+BR in TN patients
Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients
Drug: Acalabrutinib in combination with BR
Other Name: Acalabrutinib + BR

Experimental: Part 1: Acalabrutinib+BR in RR patients
Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients
Drug: Acalabrutinib in combination with BR
Other Name: Acalabrutinib + BR

Experimental: Part 2: Acalabrutinib+VR in TN patients
Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients
Drug: Acalabrutinib in combination with VR
Other Name: Acalabrutinib + VR




Primary Outcome Measures :
  1. 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 ]


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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.
  • 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.

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): NCT02717624


Locations
United States, Kentucky
Louisville, Kentucky, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, New Jersey
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
United States, New York
Lake Success, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Washington
Seattle, Washington, United States
Italy
Bologna, Italy
Poland
Krakow, Poland
Olsztyn, Poland
Warsaw, Poland
Łódź, Poland
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02717624     History of Changes
Other Study ID Numbers: ACE-LY-106
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acerta Pharma BV:
Bruton Tyrosine Kinase Inhibitor
BTK
Mantle Cell Lymphoma
MCL
Acalabrutinib
ACE-LY-106

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Venetoclax
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action