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

Sponsor

Acerta Pharma BV (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02717624

Collaborator

AstraZeneca (Industry)

Enrollment

Locations

Arms

79.3

Anticipated Duration (Months)

4.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma (MCL)	Drug: Acalabrutinib in combination with BR Drug: Acalabrutinib in combination with VR	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

N/A

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

Actual Study Start Date :

Apr 20, 2016

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: Acalabrutinib+BR in TN patients Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients	Drug: Acalabrutinib in combination with BR Other Names: Acalabrutinib + BR
Experimental: Part 1: Acalabrutinib+BR in RR patients Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients	Drug: Acalabrutinib in combination with BR Other Names: Acalabrutinib + BR
Experimental: Part 2: Acalabrutinib+VR in TN patients Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients	Drug: Acalabrutinib in combination with VR Other Names: Acalabrutinib + VR

Arm

Intervention/Treatment

Experimental: Part 1: Acalabrutinib+BR in TN patients

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

Drug: Acalabrutinib in combination with BR

Other Names:

Acalabrutinib + BR

Experimental: Part 1: Acalabrutinib+BR in RR patients

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

Drug: Acalabrutinib in combination with BR

Other Names:

Acalabrutinib + BR

Experimental: Part 2: Acalabrutinib+VR in TN patients

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

Drug: Acalabrutinib in combination with VR

Other Names:

Acalabrutinib + VR

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Louisville	Kentucky	United States	40207
2	Research Site	Ann Arbor	Michigan	United States	48109
3	Research Site	Hackensack	New Jersey	United States	07601
4	Research Site	Morristown	New Jersey	United States	07960
5	Research Site	Lake Success	New York	United States	11042
6	Research Site	Columbus	Ohio	United States	43210
7	Research Site	Nashville	Tennessee	United States	37203
8	Research Site	Houston	Texas	United States	77030
9	Research Site	Seattle	Washington	United States	98109
10	Research Site	Seattle	Washington	United States	98122
11	Research Site	Bologna		Italy	40138
12	Research Site	Krakow		Poland	30-510
13	Research Site	Lodz		Poland	93-510
14	Research Site	Olsztyn		Poland	10-228
15	Research Site	Warszawa		Poland	02-106