A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
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| ClinicalTrials.gov Identifier: NCT02717624 |
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Recruitment Status :
Active, not recruiting
First Posted : March 24, 2016
Last Update Posted : December 3, 2018
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Sponsor:
Acerta Pharma BV
Information provided by (Responsible Party):
Acerta Pharma BV
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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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1: Acalabrutinib+BR in TN patients
Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients
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Drug: Acalabrutinib in combination with BR
Other Name: Acalabrutinib + BR |
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Experimental: Part 1: Acalabrutinib+BR in RR patients
Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients
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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
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Drug: Acalabrutinib in combination with VR
Other Name: Acalabrutinib + VR |
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 ]
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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:
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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 Venetoclax |
Rituximab Bendamustine Hydrochloride Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |