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

Phase 1

Active, not recruiting

• Conditions: Mantle Cell Lymphoma (MCL)
• Interventions: Drug: Acalabrutinib in combination with BR; Drug: Acalabrutinib in combination with VR

• Registration Number: NCT02717624
• Lead Sponsor: 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

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).

Study Timeline

• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-24
• Study Start: 2016-04-20
• Primary Completion: 2022-06-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Study Completion: 2027-08-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1: Acalabrutinib+BR in RR patients	Acalabrutinib in combination with BR	Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients
Part 1: Acalabrutinib+BR in TN patients	Acalabrutinib in combination with BR	Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients
Part 2: Acalabrutinib+VR in TN patients	Acalabrutinib in combination with VR	Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Research Site; 🇵🇱 Warszawa, Poland