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Protein Kinase Inhibitor

Combination Chemotherapy + Acalabrutinib for Mantle Cell Lymphoma

Phase 2

Recruiting

Led By Stephen D Smith

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2

Documented, fludeoxyglucose F-18 (FDG)-avid measurable disease (at least 1 lesion >= 1.5 cm in diameter) as detected by positron emission tomography (PET)/computed tomography (CT) and as defined and includes measurable nodal and extranodal disease sites, or splenomegaly measuring more than 13 cm in vertical length

Must not have

Active systemic fungal, bacterial, viral, or other infection that is worsening (defined as increasing signs/symptoms of infection during screening) or, requires intravenous antibiotic therapy

Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of registration to the date of progression (or relapse),or death due to any cause, whichever comes first, assessed at 2 years post-registration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well a combination of drugs works as first line treatment for mantle cell lymphoma. The drugs work in different ways to stop the growth of cancer cells.

Who is the study for?

This trial is for transplant-eligible patients aged 18-75 with mantle cell lymphoma who haven't had prior systemic treatment. They must have measurable disease, acceptable organ function, and an ECOG performance status of 0-2. Women of childbearing potential and men must agree to effective contraception during the study and afterwards.

What is being tested?

The trial investigates a modified VR-CAP (a combination of chemotherapy drugs) plus acalabrutinib as first-line therapy compared to standard treatments. It aims to see if this new combo is more effective in treating mantle cell lymphoma before a patient undergoes a stem cell transplant.

What are the potential side effects?

Potential side effects include reactions from monoclonal antibodies like Rituximab, chemo-related nausea, hair loss, fatigue, increased risk of infection due to low blood counts, liver toxicity indicated by elevated bilirubin or AST levels, and possible bleeding complications.

Eligibility Criteria

Inclusion Criteria

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

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

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My scans show at least one cancer spot larger than 1.5 cm or an enlarged spleen.

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I am between 18 and 75 years old.

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I have not received any treatment for mantle cell lymphoma.

Exclusion Criteria

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

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I do not have an active infection that is getting worse or needs IV antibiotics.

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I have uncontrolled AIHA or ITP.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

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I need treatment with a strong medication that affects liver enzymes.

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I do not have any severe illnesses that could interfere with the study.

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I do not have a bleeding disorder like hemophilia.

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I am not on any experimental drugs for my cancer.

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I am allergic to acalabrutinib, cytarabine, bortezomib, boron, or drugs used in this study.

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I have been treated with bortezomib or a BTK inhibitor before.

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I have moderate to severe nerve pain or damage.

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I am on warfarin or a similar blood thinner.

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I have not had major surgery in the last 28 days or have fully recovered from it.

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I am HIV positive and understand there may be drug interactions with my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration to death due to any cause, assessed at 2 years post-registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration to death due to any cause, assessed at 2 years post-registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to death due to any cause, assessed at 2 years post-registration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of complete responses to therapy (complete metabolic response [CMR])

Secondary study objectives

Feasibility of stem cell collection

Incidence of adverse events

MRD rate

+4 more

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: Treatment (modified VR-CAP, acalabrutinib)Experimental Treatment8 Interventions

CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860