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Acalabrutinib + Chemotherapy for Waldenstrom's Macroglobulinemia (BRAWM Trial)
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.
BRAWM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBRAWM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 177 Patients • NCT04346199BRAWM Trial Design
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Who is running the clinical trial?
Media Library
- I have a history of active tuberculosis.I have had treatment for Waldenstrom macroglobulinemia before.I haven't had any drug treatments for my condition, but treatments like plasmapheresis, specific radiation, or corticosteroids for symptoms are okay.My high blood pressure cannot be controlled with medication.My lymphoma is causing symptoms or is about to cause symptoms.I do not have an active infection needing treatment.I am 18 years or older and have agreed to participate.I have severe stomach issues that prevent me from properly absorbing medication.I am using or willing to use two effective birth control methods or I am not able to have children.I haven't taken strong immune system suppressing drugs in the last 35 days.I do not have serious heart problems or recent heart attacks.I have active Hepatitis B or C, or I am on Hepatitis B prophylaxis with negative HBV DNA.I am scheduled for a stem cell transplant using my own cells.I have had lung inflammation not caused by infection, treated within the last 5 years.I have a recent biopsy confirming Waldenstrom's macroglobulinemia.My recent tests show my organs are working well enough for the trial.I am not willing to stop or change my warfarin or proton pump inhibitor medication before joining.I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.My cancer can be measured by scans or blood tests.I have another cancer besides skin or in situ cervical cancer that is getting worse or needs treatment.I have not had a live virus vaccine in the last 28 days.I have not had major surgery in the last 30 days or have fully recovered if I did.I agree to use effective birth control during and after my treatment as required.The doctor believes you will live for at least 6 more months.I can take care of myself and am up and about more than 50% of my waking hours.I have a bleeding disorder like hemophilia.I do not have a serious illness that could make treatment risky.I am not on strong CYP3A inhibitors or inducers, or haven't been for 3 weeks.I have not had a stroke or brain bleed in the last 6 months.I am a woman who can have children and have a negative pregnancy test within the last 3 days.I have stable brain metastases and haven't used steroids for them in over 35 days.I have been diagnosed with HIV.
- Group 1: Single arm intervention
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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