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

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Sponsor:

Information provided by (Responsible Party):

Acerta Pharma BV

Study Description

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 Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Drug Information available for: Bendamustine hydrochloride Bendamustine Rituximab Venetoclax Acalabrutinib

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Mantle Cell Lymphoma

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

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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.

Contacts and Locations

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

Contacts

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Contact: Acerta Clinical Trials	1-888-292-9613	acertamc@dlss.com

Locations

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United States, Kentucky
	Active, not recruiting
Louisville, Kentucky, United States
United States, Michigan
	Active, not recruiting
Ann Arbor, Michigan, United States
United States, New Jersey
	Recruiting
Florham Park, New Jersey, United States
	Recruiting
Hackensack, New Jersey, United States
United States, New York
	Active, not recruiting
Lake Success, New York, United States
United States, Ohio
	Recruiting
Columbus, Ohio, United States
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States
United States, Texas
	Active, not recruiting
Houston, Texas, United States
United States, Washington
	Active, not recruiting
Seattle, Washington, United States
	Recruiting
Seattle, Washington, United States
Italy
	Recruiting
Bologna, Italy
Poland
	Recruiting
Krakow, Poland
	Recruiting
Olsztyn, Poland
	Recruiting
Warsaw, Poland
	Recruiting
Łódź, Poland

Sponsors and Collaborators

Acerta Pharma BV

Investigators

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Study Director:	Acerta Clinical Trials	1-888-292-9613; acertamc@dlss.com

More Information

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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:	March 28, 2019
Last Verified:	March 2019

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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 Rituximab	Bendamustine Hydrochloride Venetoclax Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action

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