What side effects are associated with this type of intervention?

Common treatments for Central Nervous System Lymphoma (CNSL) include chemotherapy, radiation therapy, and targeted therapies like BTK inhibitors. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, and increased risk of infections. Radiation therapy may lead to fatigue, skin changes, and cognitive deficits. BTK inhibitors, such as Acalabrutinib, are generally well-tolerated but can cause headaches, diarrhea, and increased risk of infections. It is important to discuss potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for BTK inhibitors like Acalabrutinib in the treatment of Central Nervous System Lymphoma (CNSL). Generally, treatments for CNSL have included high-dose methotrexate-based chemotherapy, often combined with other agents such as cytarabine, and sometimes followed by autologous stem cell transplantation. Rituximab, an anti-CD20 monoclonal antibody, has also been used in combination with chemotherapy for CNSL. Emerging treatments and investigational therapies continue to be explored in clinical trials.

What other types of research exist?

Promising novel alternatives to Acalabrutinib for CNSL patients include: 1) Abemaciclib, which has shown intracranial activity in brain metastases from breast cancer, suggesting potential efficacy in CNSL. 2) Palbociclib, which has demonstrated intracranial activity in brain metastases with cyclin-dependent kinase pathway alterations. 3) Tucatinib, in combination with Trastuzumab and Capecitabine, which has shown efficacy in HER2-positive brain metastases. These therapies are being explored for their potential to treat CNSL due to their ability to penetrate the central nervous system and target relevant pathways.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Lymphoma

Phase 1 & 2

Recruiting

Led By Lakshmi Nayak, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Acalabrutinib, a drug used in other cancers, to see if it can help people with a type of brain cancer that hasn't responded to other treatments. The drug works by stopping the cancer cells from growing.

Who is the study for?

Adults with recurrent or refractory central nervous system lymphoma (CNSL) who have had at least one prior CNS-directed therapy can join this trial. They must be able to understand and sign consent, have a life expectancy over 3 months, an ECOG Performance Status of 0-1, and meet specific health criteria like adequate blood counts and organ function. Pregnant women, those unable to swallow pills or with certain infections or bleeding disorders cannot participate.

What is being tested?

The trial is testing the safety and effectiveness of Acalabrutinib for people whose CNSL has come back after treatment or didn't respond to previous treatments. It's in phases 1/2 which means they're starting to see how well it works and what doses are safe.

What are the potential side effects?

Potential side effects of Acalabrutinib may include headache, diarrhea, muscle pain, reduced blood cell counts leading to increased infection risk or bruising, irregular heartbeat among others. Each person might experience these differently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum-tolerated dose (MTD)

Secondary study objectives

Duration of response (DOR)

Objective response rate (ORR).

Overall survival (OS)

+2 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Acalabrutinib Dose ExpansionExperimental Treatment1 Intervention

Phase 2 Participants will receive Acalabrutinib at the pre-determined dosage established in Phase 1.

Group II: Acalabrutinib Dose EscalationExperimental Treatment1 Intervention

Phase 1 Dose escalation will occur using a 3+3 dose escalation approach, evaluating three separate dose levels. * Acalabrutinib 200mg 2x daily * Acalabrutinib 300mg 2x daily * Acalabrutinib 400mg 2x daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Central Nervous System Lymphoma (CNSL) treatments often target specific pathways involved in the growth and survival of lymphoma cells. Acalabrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, works by blocking BTK, a protein essential for the proliferation and survival of B-cells, which are often malignant in CNSL. This inhibition disrupts the signaling pathways that promote cancer cell growth, leading to cell death. Other common treatments include chemotherapy, which uses drugs to kill rapidly dividing cells, and radiation therapy, which uses high-energy rays to destroy cancer cells. These treatments are crucial for CNSL patients as they aim to control the spread of the disease within the central nervous system, improve symptoms, and extend survival.