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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 12, yearly up to 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am using effective birth control or abstaining from sex.
Select...
I have been diagnosed with IgM MGUS or Waldenström macroglobulinemia.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall hematologic response rate
Secondary outcome measures
Bone marrow response
Complete Response Rate
Minor Response (MR)
+15 moreSide effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC
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
~2050
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Shayna Sarosiek, MDLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Jorge J. Castillo, MDLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,826 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 4 weeks.I do not have an active Hepatitis B or C infection.My liver is severely impaired (Child-Pugh class C).You have a specific type of protein in your blood called IgM monoclonal paraprotein.I am currently taking proton pump inhibitors every day.I am using effective birth control or abstaining from sex.I have nerve damage not caused by IgM-mediated neuropathy.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I plan to try for a child during or within 3 months after the study.I have not had a stroke or major brain event in the last 6 months.My organs and bone marrow are functioning well.I have a current bleeding issue or a history of bleeding problems.I do not have a serious infection currently.I have been diagnosed with IgM MGUS or Waldenström macroglobulinemia.I haven't had any cancer except for certain skin, cervical, breast, or prostate cancers in the last 2 years.I am on blood thinners like warfarin.You had a stomach or intestine ulcer found by a special camera test within the last 3 months.You have had a severe allergic reaction or intolerance to rituximab, ofatumumab, or acalabrutinib in the past.My heart condition severely limits my daily activities.I have not received a live vaccine in the last 4 weeks.I haven't taken drugs that strongly affect liver enzymes within the last week.I agree to use a condom during and up to 12 months after my treatment.I have had symptoms of nerve damage for more than 5 years.I cannot take medications by mouth due to a digestive condition.I do not have serious heart issues like uncontrolled heart rhythm problems, heart failure, or a recent heart attack.I cannot swallow pills.I have not had chemotherapy, BTK inhibitors, or specific WM treatments in the last 90 days, except for steroids, IVIG, or anti-CD20 antibodies.Your IgM blood level is higher than 4,000 mg/dL.I have Waldenström macroglobulinemia and need treatment, but I don't have nerve pain in my hands or feet.I do not have MZL, CLL, MCL, IgM Myeloma, or AL amyloidosis.I do not have uncontrolled AIHA or ITP.I have been diagnosed with lymphoma in my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: ACALABRUTINIB + RITUXIMAB/BIOSIMILAR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been included in this clinical experiment?
"Affirmative. Clinicaltrials.gov displays evidence that this research is actively seeking participants; the study was first made available on November 16th 2021 and its specifications were last revised on November 14th 2022. The trial aims to enrol 33 patients from two distinct medical facilities."
Answered by AI
Has Acalabrutinib been given the green light by the FDA?
"Reviewers at our company estimate that the safety of Acalabrutinib is a score 2 due to limited clinical evidence supporting its efficacy, though some data suggests it may be safe."
Answered by AI
Are there currently opportunities to join this medical experiment?
"Affirmative. Clinicaltrials.gov outlines that this scientific trial, which made its debut on November 16th 2021, is actively recruiting volunteers. A total of 33 participants need to be sourced from 2 different medical sites."
Answered by AI
What medical conditions is Acalabrutinib utilized to treat?
"Acalabrutinib has demonstrated efficacy in the treatment of diffuse large b-cell lymphoma (DLBCL) and other conditions such as polyangiitis, pemphigus vulgaris, and various B cell lymphomas."
Answered by AI
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