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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Combination Therapy for B-Cell Lymphoma

Phase 1

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

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

Study 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.Check my eligibility

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).See study design

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.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug to within 30 days of last dose of study drug

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Treatment Emergent Adverse Events (AEs)

Side effects data

From 2016 Phase 2 trial • 31 Patients • NCT02387762

13%

Anaemia

Nausea

Leukopenia

Intervertebral disc degeneration

Dizziness

Oedema peripheral

Diarrhea

Vomiting

Full Blood Count decreased

Contusion

Thrombocytosis

Hyponatraemia

Hypochloraemia

Musculoskeletal chest pain

Haematuria

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + Methotrexate

ACP-196 + Methotrexate

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

acalabrutinib

2018

Completed Phase 2

~80

Lenalidomide

2005

Completed Phase 3

~1480

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,812 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,593,673 Total Patients Enrolled

Acerta Call centerStudy DirectorAcerta Pharma, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities still available to those interested in participating?

"Per the information on clinicaltrials.gov, this particular investigation is not presently recruiting participants. Although it was initially published in 2014 and updated last September, 2458 alternative studies are actively seeking volunteers as of now."

Answered by AI

Are there numerous medical facilities running this research project in the city?

"This research is being conducted from the University of Chicago in Lake Success, New york; Norton Cancer Center in Chicago, Illinois; and Clinical Research Alliance in Louisville, Kentucky. Additionally, there are 35 other sites participating."

Answered by AI

How many participants have registered for this clinical research project?

"Unfortunately, this trial has ceased to recruit participants. It was initially posted on December 29th 2014 and latest updated September 26th 2022. If you are seeking an alternative study, there is a total of 1796 trials related to patients with lymphoma b-cell actively recruiting as well 662 studies focused on acalabrutinib which currently require volunteers."

Answered by AI

For what indications is acalabrutinib usually prescribed?

"Acalabrutinib is recommended as a treatment for diffuse large b-cell lymphoma (dlbcl) when two or more prior systemic chemotherapy regimens have been prescribed and the individual has B-cell lymphomas."

Answered by AI

Are there any supplemental investigations exploring acalabrutinib?

"Acalabrutinib was first studied in 1993 at the NIH Clinical Center, 9000 Rockville Pike. Since then, 1125 trials have been completed and 662 are currently active - many of which are taking place near Lake Success, New york."

Answered by AI