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

Mantle Cell Lymphoma (MCL) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02717624
• Other study ID #: ACE-LY-106
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 20, 2016
• Est. completion date: August 20, 2027

Study information

• Verified date: May 2024
• Source: Acerta Pharma BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: August 20, 2027
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma (MCL)

Intervention

Drug:
• Acalabrutinib in combination with BR

• Acalabrutinib in combination with VR

Locations

Country	Name	City	State
Italy	Research Site	Bologna
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Olsztyn
Poland	Research Site	Warszawa
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Columbus	Ohio
United States	Research Site	Hackensack	New Jersey
United States	Research Site	Houston	Texas
United States	Research Site	Lake Success	New York
United States	Research Site	Louisville	Kentucky
United States	Research Site	Morristown	New Jersey
United States	Research Site	Nashville	Tennessee
United States	Research Site	Seattle	Washington
United States	Research Site	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Acerta Pharma BV	AstraZeneca

Countries where clinical trial is conducted

United States,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03	Number of participants who had experienced at least one treatment emergent AE	From first dose of study drug to within 30 days of last dose of study drug