Mantle Cell Lymphoma (MCL)Phase 1NCT02717624
A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
A Phase 1 study testing Acalabrutinib in combination with BR and Acalabrutinib in combination with VR in people with Mantle Cell Lymphoma (MCL), run by Acerta Pharma BV at 15 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma (MCL)
- What is being tested?
- Acalabrutinib in combination with BR and Acalabrutinib in combination with VR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 20 Apr 2016to 20 Aug 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States10 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Columbus, Ohio, 43210
Research Site
Hackensack, New Jersey, 07601
Research Site
Houston, Texas, 77030
Research Site
Lake Success, New York, 11042
Research Site
Louisville, Kentucky, 40207
Research Site
Morristown, New Jersey, 07960
Research Site
Nashville, Tennessee, 37203
Research Site
Seattle, Washington, 98109
Research Site
Seattle, Washington, 98122
Poland4 sites
Research Site
Krakow, 30-510
Research Site
Lodz, 93-510
Research Site
Olsztyn, 10-228
Research Site
Warsaw, 02-106
About this study
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
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
Read the 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).
- Conditions
- Mantle Cell Lymphoma (MCL)
- Being tested
- Acalabrutinib in combination with BR, Acalabrutinib in combination with VR
- Keywords
- Bruton Tyrosine Kinase Inhibitor, BTK, Mantle Cell Lymphoma, MCL, Acalabrutinib, ACE-LY-106
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acalabrutinib in combination with BRDrug
Also called Acalabrutinib + BR
Acalabrutinib in combination with VRDrug
Also called Acalabrutinib + VR
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Acalabrutinib+BR in TN patients | Experimental | Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients Receives: Drug: Acalabrutinib in combination with BR |
| Part 1: Acalabrutinib+BR in RR patients | Experimental | Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients Receives: Drug: Acalabrutinib in combination with BR |
| Part 2: Acalabrutinib+VR in TN patients | Experimental | Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients Receives: Drug: Acalabrutinib in combination with VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From first dose of study drug to within 30 days of last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start20 Apr 2016
- Primary completion15 Jun 2022
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell Lymphoma (MCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Acerta Clinical Trials, Study director, 1-888-292-9613; acertamc@dlss.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717624
- Sponsor's protocol ID
- ACE-LY-106
- Other IDs
- 2023-509353-31-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2016
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wang M, Robak T, Maddocks KJ, Phillips T, Smith SD, Gallinson D, Calvo R, Wun CC, Munugalavadla V, Jurczak W. Acalabrutinib plus venetoclax and rituximab in treatment-naive mantle cell lymphoma: 2-year safety and efficacy analysis. Blood Adv. 2024 Sep 10;8(17):4539-4548. doi: 10.1182/bloodadvances.2023012424.
PubMed 38781315