Acalabrutinib for Mantle Cell Lymphoma

Not currently recruiting at 67 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called acalabrutinib for individuals with Mantle Cell Lymphoma (MCL), a type of blood cancer that has returned or stopped responding to previous treatments. The trial aims to assess the safety and effectiveness of acalabrutinib in managing MCL. It is suitable for those diagnosed with MCL who have specific genetic markers often found in this cancer. Participants should not have severe heart problems or digestive issues that could affect the drug's performance. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that acalabrutinib is usually well-tolerated by people with mantle cell lymphoma (MCL). In a study involving patients whose MCL had returned or didn't respond to other treatments, most participants managed the treatment well. Common side effects included mild headaches and diarrhea, while serious side effects were rare.

Other studies have found that acalabrutinib is less harmful compared to some similar treatments, indicating a good safety record. Since the FDA has approved acalabrutinib for other conditions, there is some confidence in its safety for people with MCL. However, as with any treatment, individual experiences can differ, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Acalabrutinib is unique because it targets a specific protein called Bruton’s tyrosine kinase (BTK), which plays a crucial role in the growth and survival of cancer cells in mantle cell lymphoma. Unlike standard chemotherapy treatments, which can affect both cancerous and healthy cells, acalabrutinib focuses on this specific pathway, potentially reducing side effects and improving effectiveness. Researchers are excited about acalabrutinib because its targeted approach might offer a more precise and possibly more tolerable treatment option for patients with mantle cell lymphoma.

What evidence suggests that acalabrutinib might be an effective treatment for Mantle Cell Lymphoma?

Studies have shown that acalabrutinib works well for people with relapsed or hard-to-treat Mantle Cell Lymphoma (MCL). In one study, patients who took this treatment experienced prolonged periods without disease progression. Another study found that acalabrutinib remained safe and effective over time. Real-world evidence also supports its benefits, showing good results in patients who used acalabrutinib alone. These findings suggest that acalabrutinib could be a strong option for treating MCL. ^{1 3 4 6 7}

Who Is on the Research Team?

Acerta Pharma

Principal Investigator

1-888-292-9613

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/7744/528340/Real-World-Effectiveness-and-Safety-Outcomes-of

Real-World Effectiveness and Safety Outcomes of ... Results: Among 181 pts with MCL treated with acala, 127 were treated in the R/R setting (study cohort) (acala monotherapy: 94 pts; combination ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10772531/

Final results and overall survival data from a phase II study ... The final results of this study demonstrated that efficacy and safety of acalabrutinib were maintained compared with data from a previous analysis (median ...

3. haematologica.org haematologica.org/article/view/haematol.2023.284896

Safety and efficacy of acalabrutinib plus bendamustine and ... Results indicate that ABR was safe and efficacious, supporting further study in patients with TN MCL. Introduction. Mantle cell lymphoma (MCL) ...

4. onclive.com onclive.com/view/acalabrutinib-plus-br-highlights-evolving-first-line-soc-for-high-risk-mantle-cell-lymphoma

Acalabrutinib Plus BR Highlights Evolving First-Line SOC ... Additionally, the median PFS was 49.5 months (95% CI, 35.6-not evaluable) in the acalabrutinib arm vs 36.0 months (95% CI, 26.9-50.1) in the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02213926

NCT02213926 | An Open-label, Phase 2 Study of ACP-196 ... 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 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124105708

Real-World Effectiveness and Safety Outcomes of ... Results: Among 181 pts with MCL treated with acala, 127 were treated in the R/R setting (study cohort) (acala monotherapy: 94 pts; combination ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00690

Acalabrutinib Plus Bendamustine-Rituximab in Untreated ... Acalabrutinib was shown to be efficacious and less toxic than ibrutinib in a head-to-head trial in chronic lymphocytic leukemia and therefore ...