Acalabrutinib for Waldenstrom Macroglobulinemia

Phase-Based Progress Estimates
McGill University Health Centre, Montréal, CanadaWaldenstrom MacroglobulinemiaAcalabrutinib - Drug
All Sexes
What conditions do you have?

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 6 year post first dose

6 and 12 months
Overall objective response and partial response
Day 30
Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v5.0)]
Year 6
Time to Next Treatment
Year 6
Documentation of overall survival
Documentation of progression free survival
Duration of Response
Year 1
Best combined complete response (CR) and very good partial response (VGPR)
Month 18
Documentation of minimal residual disease (MRD) rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Side Effects for

BSC Alone
1%Septic shock
1%Ischaemic stroke
1%Chronic obstructive pulmonary disease
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT04346199) in the BSC Alone ARM group. Side effects include: Headache with 2%, Septic shock with 1%, Ischaemic stroke with 1%, Chronic obstructive pulmonary disease with 1%.

Trial Design

1 Treatment Group

Single arm intervention
1 of 1

Experimental Treatment

59 Total Participants · 1 Treatment Group

Primary Treatment: Acalabrutinib · No Placebo Group · Phase 2

Single arm interventionExperimental Group · 3 Interventions: Acalabrutinib, Bendamustine, Rituximab · Intervention Types: Drug, Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 year post first dose

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,020 Previous Clinical Trials
240,381,377 Total Patients Enrolled
2 Trials studying Waldenstrom Macroglobulinemia
82 Patients Enrolled for Waldenstrom Macroglobulinemia
Sunnybrook Health Sciences CentreLead Sponsor
607 Previous Clinical Trials
1,468,162 Total Patients Enrolled
Neil L Berinstein, MDPrincipal InvestigatorSunnybrook Research Institute
1 Previous Clinical Trials
25 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 13 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The doctor thinks you will live for at least 6 more months.

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Is patient recruitment for this trial still open?

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.