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

Acerta Pharma

Status and phase: Active, not recruiting; Phase 1

Conditions: Mantle Cell Lymphoma (MCL)

Treatments: Drug: Acalabrutinib in combination with BR; Drug: Acalabrutinib in combination with VR

Study type: Interventional

Funder types: Industry

Identifiers

NCT02717624

2023-509353-31-00 (Registry Identifier)

ACE-LY-106

Details and patient eligibility

About

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

Full 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).

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Part 1: Acalabrutinib+BR in TN patients

Experimental group

Description:

Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients

Treatment:

Drug: Acalabrutinib in combination with BR

Part 1: Acalabrutinib+BR in RR patients

Experimental group

Description:

Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients

Treatment:

Drug: Acalabrutinib in combination with BR

Part 2: Acalabrutinib+VR in TN patients

Experimental group

Description:

Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients

Treatment:

Drug: Acalabrutinib in combination with VR