Acalabrutinib for Mantle Cell Lymphoma

Recruiting at 58 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Acerta Pharma BV

Disqualifiers: Cardiovascular disease, Malabsorption, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 5

Duration: Up to approximately 4 years and 10 months

124 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug acalabrutinib for treating mantle cell lymphoma?

Acalabrutinib has been shown to be effective for mantle cell lymphoma, with a clinical trial demonstrating an overall response rate of 81% in patients whose disease had returned or was resistant to other treatments. ^{1 2 3 4 5}

Is acalabrutinib safe for humans?

Acalabrutinib is generally considered safe for humans, with serious adverse reactions being rare. Common side effects include headaches, which usually go away within a month without treatment, and it has fewer drug interactions compared to similar treatments. ^{1 4 5 6 7}

How is the drug acalabrutinib different from other treatments for mantle cell lymphoma?

Acalabrutinib is a highly selective Bruton tyrosine kinase inhibitor, which means it specifically targets and blocks a protein involved in the growth of cancer cells, minimizing effects on other parts of the body. It is taken orally and has shown a high response rate in patients with relapsed mantle cell lymphoma, offering a new option for those who have not responded to other treatments. ^{1 2 3 4 5}

Research Team

Acerta Pharma

Principal Investigator

1-888-292-9613

Eligibility Criteria

This trial is for adults over 18 with confirmed Mantle Cell Lymphoma (MCL) who have relapsed or are not responding to treatment. Participants must be relatively fit (ECOG ≤ 2), able to use contraception, and not have severe illnesses that could risk their safety or affect the study drug's absorption.

Inclusion Criteria

Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children

My Mantle Cell Lymphoma (MCL) has specific genetic markers.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I do not have serious heart problems like recent heart attacks or severe heart failure.

I do not have significant issues with my digestive system.

Breast feeding or pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 100 mg of acalabrutinib twice per day in repeated 28-day cycles until disease progression or unacceptable toxicity

Up to approximately 4 years and 10 months

Weekly visits for the first 4 weeks, bi-weekly in Cycle 2, monthly in Cycles 3-12, and every 24 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ACP-196 (acalabrutinib)

Trial Overview The trial is testing ACP-196 (acalabrutinib) for its effectiveness and safety in patients with MCL that has come back or isn't getting better. It's an open-label, Phase 2 study which means everyone knows they're receiving acalabrutinib and it’s fairly early in the clinical trials process.

Participant Groups

Group I: ACP-196 (acalabrutinib) Regimen 1 Experimental Treatment 1 Intervention

ACP-196 (acalabrutinib) Regimen 1

Who Is Running the Clinical Trial?

Acerta Pharma BV

Lead Sponsor

Trials

46

Recruited

5,900+

Findings from Research

Acalabrutinib demonstrated significantly higher overall response rates (ORR) and complete response (CR) rates compared to other targeted therapies for relapsed/refractory mantle cell lymphoma (MCL), indicating its efficacy in treating this condition.

The safety profile of acalabrutinib was comparable or better than that of other monotherapies, although it did show increased risks of infection and anemia compared to certain combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-adjusted Indirect Comparisons of the Efficacy and Safety of Acalabrutinib Versus Other Targeted Therapies in Relapsed/Refractory Mantle Cell Lymphoma. Telford, C., Kabadi, SM., Abhyankar, S., et al.[2021]

Acalabrutinib, an oral Bruton tyrosine kinase inhibitor, has shown an impressive overall response rate of 81% in patients with relapsed mantle cell lymphoma (MCL), indicating its efficacy as a treatment option.

This novel therapy is not only approved for relapsed MCL but is also being tested as a first-line treatment, highlighting its potential to improve outcomes for patients with this challenging type of lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acalabrutinib for mantle cell lymphoma. Witzig, TE., Inwards, D.[2021]

In a phase 2 trial involving 124 patients with relapsed or refractory mantle cell lymphoma, acalabrutinib was associated with common treatment-related adverse events (AEs) like headache and diarrhea, but these did not lead to any treatment discontinuations.

Effective management strategies, including patient education and the use of over-the-counter medications for mild AEs, helped maintain treatment adherence and allowed for better tracking and management of nonadherence issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acalabrutinib: Managing Adverse Events and Improving Adherence in Patients With Mantle Cell Lymphoma. Badillo, M., Nava, D., Rosa, M., et al.[2022]

Acalabrutinib (Calquence®) has received accelerated approval from the US FDA for treating mantle cell lymphoma, based on promising results from a phase II study.

Phase III trials are currently ongoing for acalabrutinib in mantle cell lymphoma and chronic lymphocytic leukaemia, indicating its potential for broader application in treating hematological cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acalabrutinib: First Global Approval. Markham, A., Dhillon, S.[2018]

Acalabrutinib, a selective BTK inhibitor, is effective for treating mantle cell lymphoma (MCL) in patients who have already undergone at least one therapy, with serious side effects being rare.

While common side effects like headaches are generally mild and resolve quickly, patients should be cautious about drug interactions and consult their physician before taking additional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of acalabrutinib in patients with mantle cell lymphoma. Awan, FT., Jurczak, W.[2021]

Ibrutinib and acalabrutinib are effective BTK inhibitors that have been approved for treating relapsed or refractory mantle cell lymphoma (MCL), showing significant therapeutic benefits in clinical trials.

Acalabrutinib has a greater selectivity for BTK compared to ibrutinib, which reduces the risk of certain side effects like atrial fibrillation, although both drugs can still cause headaches and other toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bruton tyrosine kinase inhibitors for the treatment of mantle cell lymphoma: review of current evidence and future directions. Bond, DA., Alinari, L., Maddocks, K.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Matching-adjusted Indirect Comparisons of the Efficacy and Safety of Acalabrutinib Versus Other Targeted Therapies in Relapsed/Refractory Mantle Cell Lymphoma. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Acalabrutinib for mantle cell lymphoma. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Acalabrutinib: Managing Adverse Events and Improving Adherence in Patients With Mantle Cell Lymphoma. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Acalabrutinib: First Global Approval. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Use of acalabrutinib in patients with mantle cell lymphoma. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Bruton tyrosine kinase inhibitors for the treatment of mantle cell lymphoma: review of current evidence and future directions. [2021]