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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Chemotherapy for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By Brad S Kahl, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Eligible for autologous stem cell transplantation.

- Creatinine ≤ IULN OR creatinine clearance ≥ 40 mL/min for patients with creatinine levels above institutional normal

Must not have

A history of allergic reactions attributed to compounds of similar chemical or biologic composition to acalabrutinib, rituximab, cytarabine, bendamustine, or other agents used in the study.

Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to see if adding the drug acalabrutinib to a standard treatment regimen for mantle cell lymphoma is safe and improves outcomes.

Who is the study for?

This trial is for adults aged 18-70 with untreated mantle cell lymphoma who are eligible for stem cell transplantation. Participants must have adequate organ and bone marrow function, no history of significant bleeding disorders or major surgery within the last month, and not be on certain medications like strong CYP3A4 inhibitors or proton pump inhibitors. Pregnant or breastfeeding women cannot join.

What is being tested?

The study tests acalabrutinib combined with bendamustine/rituximab followed by cytarabine/rituximab in patients with mantle cell lymphoma. The goal is to see if this regimen before a stem cell transplant can improve response rates and outcomes compared to current treatments.

What are the potential side effects?

Potential side effects include allergic reactions to the drugs used, bleeding complications, infections due to lowered immunity from chemotherapy, liver problems indicated by changes in blood tests, digestive issues that might affect drug absorption, and heart rhythm disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for a stem cell transplant using my own cells.

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My kidney function is within the normal range or slightly above.

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My cancer can be measured on a PET scan.

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

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I am between 18 and 70 years old.

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My lymphoma is confirmed to be mantle cell type with specific genetic markers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to certain medications used in this study.

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I need medication that strongly affects liver enzyme levels.

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I have a condition that affects how my body absorbs food.

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I am HIV-positive and on antiretroviral therapy.

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I am taking warfarin or similar blood thinners.

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I have not had a stroke or brain bleed in the last 6 months.

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I have been treated with a BTK inhibitor before.

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I have symptoms from lymphoma in my brain.

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I have not had major surgery in the last 28 days or have fully recovered if I did.

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I do not have active bleeding or a history of bleeding disorders like hemophilia.

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I have uncontrolled AIHA or ITP.

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I do not have an ongoing infection that is not improving with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 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

Stem Cell Mobilization Success Rate With Cytarabine and Rituximab

Secondary study objectives

Overall Response Rate (ORR = Complete Response (CR) + Partial Response (PR)) of Subjects

Overall Survival (OS)

Pre-transplant Complete Response Rate

+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

1Treatment groups

Experimental Treatment

Group I: Bendamustine/Rituximab/Acalabrutinib/CytarabineExperimental Treatment8 Interventions

* Patients will receive (6) 28 day cycles * Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28. * Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard * After Cycle 6, patients will undergo leukapheresis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Acalabrutinib

2020

Completed Phase 2

~2080