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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Rituximab for Peripheral Neuropathy

Phase 2

Recruiting

Led By Shayna R. Sarosiek, MD

Research Sponsored by Shayna Sarosiek, MD

Eligibility Criteria Checklist

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

Must have

Females of childbearing potential must use highly effective contraception or have complete abstinence from heterosexual intercourse

Diagnosis of IgM MGUS or Waldenström macroglobulinemia using the specified criteria

Must not have

Major surgery within 4 weeks of first dose of study drug

Active infection with Hepatitis B virus (HBV) or viral hepatitis C (HCV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 12, yearly up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is researching whether combining these two drugs is safe and effective for treating people with IgM monoclonal gammopathy of undetermined significance or Waldenström macroglobulinemia-related neuropathies.

Who is the study for?

This trial is for people with IgM MGUS or Waldenström macroglobulinemia who have peripheral neuropathy. They must have good organ function, agree to use effective contraception, and be able to follow the study plan. Excluded are those with high serum IgM levels, prior chemotherapy/BTK inhibitors (except certain treatments over 90 days ago), other active cancers within 2 years (with some exceptions), uncontrolled diseases like heart failure or infections, and inability to take oral medication.

What is being tested?

The trial tests a combination of acalabrutinib (a new treatment) and rituximab (or similar CD20 antibody) against neuropathies related to IgM MGUS or Waldenström macroglobulinemia. It aims to find out if this drug duo is safe and more effective compared to current standard therapies.

What are the potential side effects?

Possible side effects include allergic reactions, bleeding issues due to blood thinners being prohibited during the trial, potential heart problems in those with pre-existing conditions, liver complications in participants with chronic liver disease, and gastrointestinal issues since individuals with ulcers are excluded.

Eligibility Criteria

Inclusion Criteria

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

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I am using effective birth control or abstaining from sex.

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I have been diagnosed with IgM MGUS or Waldenström macroglobulinemia.

Exclusion Criteria

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

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I have not had major surgery in the last 4 weeks.

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I do not have an active Hepatitis B or C infection.

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My liver is severely impaired (Child-Pugh class C).

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I am currently taking proton pump inhibitors every day.

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I have nerve damage not caused by IgM-mediated neuropathy.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I plan to try for a child during or within 3 months after the study.

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I have a current bleeding issue or a history of bleeding problems.

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I do not have a serious infection currently.

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I am on blood thinners like warfarin.

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My heart condition severely limits my daily activities.

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I have not received a live vaccine in the last 4 weeks.

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I haven't taken drugs that strongly affect liver enzymes within the last week.

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I have had symptoms of nerve damage for more than 5 years.

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I cannot take medications by mouth due to a digestive condition.

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I cannot swallow pills.

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I have Waldenström macroglobulinemia and need treatment, but I don't have nerve pain in my hands or feet.

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I do not have MZL, CLL, MCL, IgM Myeloma, or AL amyloidosis.

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I do not have uncontrolled AIHA or ITP.

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I have been diagnosed with lymphoma in my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 12, yearly up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 12, yearly up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 12, yearly up to 4 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

Overall hematologic response rate

Secondary study objectives

Bone marrow response

Complete Response Rate

Minor Response (MR)

+15 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: ACALABRUTINIB + RITUXIMAB/BIOSIMILARExperimental Treatment2 Interventions

Acalabrutinib and rituximab (or biosimilar) with be contained in the treatment regimen. Acalabrutinib will be administered twice daily, with 28 consecutive days defined as a treatment cycle. Acalabrutinib will be administered for 48 cycles or until disease progression or unacceptable toxicity. Rituximab will be administered on Days 1, 8, 15, and 22 of Cycles 1 and 4. Participants will have study visits every cycle for cycles 1-6, then every 3 cycles, with the next visit at Cycle 9, then C12, C15, etc. Participants will continue acalabrutinib until disease progression or intolerable adverse effect develops. They will be followed for up to 2 years after completion of 48 cycles of treatment or until death

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

Rituximab

1999

Completed Phase 4

~2990