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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Combination Therapy for B-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Acerta Pharma BV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Histologically confirmed MZL including splenic, nodal, and extranodal sub-types
- Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma must be Helicobacter pylori (HP)-negative
Must not have
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
Significant cardiovascular disease such as uncontrolled or 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, or Qtc >480 msec
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug to within 30 days of last dose of study drug
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a new drug for people with a certain kind of cancer.

Who is the study for?
Adults over 18 with certain types of B-cell Non-Hodgkin Lymphoma that have relapsed or didn't respond to previous treatments. Participants must not be pregnant, should agree to use contraception if they can have children, and cannot have serious heart issues or gastrointestinal conditions that could affect the study.
What is being tested?
The trial is testing Acalabrutinib alone or combined with Rituximab for relapsed/refractory Follicular Lymphoma (FL), and its combination with Rituximab and Lenalidomide for the same condition. It aims to assess safety and effectiveness, including overall response rate in Marginal Zone Lymphoma (MZL).
What are the potential side effects?
Potential side effects include digestive problems, heart rhythm issues, increased risk of infections due to weakened immune system responses, fatigue, headaches, muscle aches, and possibly severe reactions related to blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is a type of marginal zone lymphoma.
Select...
I have MALT lymphoma and am not infected with Helicobacter pylori.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have significant issues with my digestive system.
Select...
I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug to within 30 days of last dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug to within 30 days of last dose of study drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment Emergent Adverse Events (AEs)

Side effects data

From 2016 Phase 2 trial • 31 Patients • NCT02387762
13%
Anaemia
6%
Musculoskeletal chest pain
6%
Dizziness
6%
Nausea
6%
Oedema peripheral
6%
Thrombocytosis
6%
Full Blood Count decreased
6%
Leukopenia
6%
Hyponatraemia
6%
Haematuria
6%
Intervertebral disc degeneration
6%
Contusion
6%
Hypochloraemia
6%
Vomiting
6%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Methotrexate
ACP-196 + Methotrexate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 3: acalabrutinib Regimen 1Experimental Treatment3 Interventions
acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
Group II: Part 2: acalabrutinib Regimen 2Experimental Treatment2 Interventions
acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
Group III: Part 2: acalabrutinib Regimen 1Experimental Treatment1 Intervention
acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
Group IV: Part 1: acalabrutinib Regimen 2Experimental Treatment2 Interventions
acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
Group V: Part 1: acalabrutinib Regimen 1Experimental Treatment1 Intervention
acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~2240
acalabrutinib
2018
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
5,812 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,544 Total Patients Enrolled
Acerta Call centerStudy DirectorAcerta Pharma, LLC
~10 spots leftby Nov 2025
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