Clinical Trials in Italy / NCT02717624
Active, not recruiting
Phase 1
A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
NCT02717624 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Mantle Cell Lymphoma (MCL)
Investigational drug(s) / intervention(s)
Study 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
Eligibility
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.
Primary outcome measure(s)
- Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03 — 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
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Louisville | Kentucky | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Hackensack | New Jersey | |
| Research Site | Morristown | New Jersey | |
| Research Site | Lake Success | New York | |
| Research Site | Columbus | Ohio | |
| Research Site | Nashville | Tennessee | |
| Research Site | Houston | Texas | |
| Research Site | Seattle | Washington | |
| Research Site | Seattle | Washington | |
| Research Site | Bologna | Italy | |
| Research Site | Krakow | Poland | |
| Research Site | Lodz | Poland | |
| Research Site | Olsztyn | Poland | |
| Research Site | Warsaw | Poland |
More Acerta Pharma BV trials in Italy
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Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
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An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
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Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02717624 on ClinicalTrials.gov ↗ ← All trials in Italy