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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717624
Recruitment Status : Active, not recruiting
First Posted : March 24, 2016
Last Update Posted : June 14, 2022
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
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

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

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
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
Actual Study Start Date : April 20, 2016
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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 ]
    Number of participants who had experienced at least one treatment emergent AE



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, 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
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United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40207
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Research Site
Hackensack, New Jersey, United States, 07601
Research Site
Morristown, New Jersey, United States, 07960
United States, New York
Research Site
Lake Success, New York, United States, 11042
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, Washington
Research Site
Seattle, Washington, United States, 98109
Research Site
Seattle, Washington, United States, 98122
Italy
Research Site
Bologna, Italy, 40138
Poland
Research Site
Krakow, Poland, 30-510
Research Site
Lodz, Poland, 93-510
Research Site
Olsztyn, Poland, 10-228
Research Site
Warszawa, Poland, 02-106
Sponsors and Collaborators
Acerta Pharma BV
AstraZeneca
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02717624    
Other Study ID Numbers: ACE-LY-106
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022

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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:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Acalabrutinib
Antineoplastic Agents