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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Chemotherapy for Waldenstrom's Macroglobulinemia (BRAWM Trial)

Phase 2
Recruiting
Led By Neil L Berinstein, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have not received any systemic treatment for the disease (plasmapheresis, involved field radiation or corticosteroids (for contrast enhanced studies and to acutely control disease-related symptoms or as chemotherapy premedication)) are allowed
Have symptomatic or impending symptomatic disease or evidence of hematologic or biochemical compromise related to the lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 year post first dose
Awards & highlights

BRAWM Trial Summary

This trial is testing a new drug, Acalabrutinib, as a treatment for Waldenstrom's Macroglobulinemia, a cancer of the blood. The study will last for one year, and participants will take the drug twice a day.

Who is the study for?
This trial is for adults with untreated Waldenstrom's Macroglobulinemia, a type of lymphoma. Participants must have a life expectancy over 6 months, be willing to use effective birth control methods, and have adequate organ function. They should not have had previous systemic treatments for the disease (except certain allowed therapies) and must be able to comply with study requirements.Check my eligibility
What is being tested?
The trial tests Acalabrutinib in combination with standard-of-care Bendamustine and Rituximab in patients who haven't been treated before. It's an open-label phase II study where participants receive Bendamustine intravenously on two days per cycle, Rituximab either intravenously or subcutaneously once per cycle, and take Acalabrutinib orally twice daily for one year.See study design
What are the potential side effects?
Potential side effects include infusion reactions from Bendamustine and Rituximab such as fever or chills; low blood counts leading to increased infection risk; nausea; fatigue; bruising or bleeding due to Acalabrutinib. Organ inflammation could also occur due to immune system activation by these drugs.

BRAWM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had any drug treatments for my condition, but treatments like plasmapheresis, specific radiation, or corticosteroids for symptoms are okay.
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My lymphoma is causing symptoms or is about to cause symptoms.
Select...
I am 18 years or older and have agreed to participate.
Select...
I am using or willing to use two effective birth control methods or I am not able to have children.
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I have a recent biopsy confirming Waldenstrom's macroglobulinemia.
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My recent tests show my organs are working well enough for the trial.
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My cancer can be measured by scans or blood tests.
Select...
I agree to use effective birth control during and after my treatment as required.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I am a woman who can have children and have a negative pregnancy test within the last 3 days.

BRAWM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 year post first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 year post first dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best combined complete response (CR) and very good partial response (VGPR)
Secondary outcome measures
Documentation of minimal residual disease (MRD) rate
Documentation of overall survival
Documentation of progression free survival
+4 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
12%
Headache
2%
Respiratory failure
2%
Pneumonia
1%
Hypotension
1%
Acute kidney injury
1%
Pleural effusion
1%
Bacterial sepsis
1%
Mucosal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acalabrutinib + BSC
BSC Alone

BRAWM Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm interventionExperimental Treatment3 Interventions
100 mg Acalabrutinib (ACP-196) oral capsules twice daily for 1 year Bendamustine and rituximab will be given for 6 x 28-day cycles. Bendamustine will be given intravenously at 90 mg/m2 on days 1 and 2 of each cycle. Rituximab will be given on day 1 of each cycle (375 mg/m2 intravenously for the first cycle and 1400 mg subcutaneously OR 375 mg/m2 intravenously for subsequent cycles (as per institutional procedures).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
FDA approved
Bendamustine
FDA approved
Rituximab
FDA approved

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
654 Previous Clinical Trials
1,543,238 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,528,148 Total Patients Enrolled
2 Trials studying Waldenstrom Macroglobulinemia
82 Patients Enrolled for Waldenstrom Macroglobulinemia
Neil L Berinstein, MDPrincipal InvestigatorSunnybrook Research Institute
1 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04624906 — Phase 2
Waldenstrom Macroglobulinemia Research Study Groups: Single arm intervention
Waldenstrom Macroglobulinemia Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04624906 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04624906 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Acalabrutinib gone through the FDA's approval process?

"Acalabrutinib's safety is estimated to be a 2. This is due to it being in Phase 2 of clinical trials, where there is data supporting its safety but not yet efficacy."

Answered by AI

What does the research say about Acalabrutinib's efficacy?

"Acalabrutinib was first evaluated in 1993 at the National Institutes of Health Clinical Center. As of now, 899 clinical trials have been completed with 511 more currently underway; a large portion these are based in Ottawa, Canada."

Answered by AI

What are the benefits of Acalabrutinib?

"Acalabrutinib has been shown to be effective in treating patients with diffuse large b-cell lymphoma (DLBCL), Hodgkin disease, and various other B-cell lymphomas."

Answered by AI

In how many different places is this trial taking place?

"The Ottawa Hospital, QEII Health Sciences Centre, Sunnybrook Health Sciences Centre, and 4 other locations are running this trial."

Answered by AI

How many individuals are experiencing this treatment as part of the research?

"In order to complete this clinical study, 59 patients that fit the pre-determined inclusion criteria must be recruited. These potential participants can be sourced from medical facilities such as The Ottawa Hospital located in Ottawa, Ontario and QEII Health Sciences Centre situated in Halifax, Nova Scotia."

Answered by AI

Is patient recruitment for this trial still open?

"Yes, this trial is still recruiting patients. Information on clinicaltrials.gov reveals that the listing was first posted on March 2nd 2021 and updated most recently on July 23rd 2021."

Answered by AI
~11 spots leftby Dec 2024