Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624906
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2020-10-23
Brief Title:
Bendamustine Rituximab and Acalabrutinib in Waldenstroms Macroglobulinemia
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
A Multi-Center Open-Label Single-Arm Phase II Trial of Bendamustine Rituximab and the Second Generation BTK Inhibitor Acalabrutinib in Previously Untreated Waldenstroms Macroglobulinemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAWM
Brief Summary:
This is a multi-centre open label single-arm phase II clinical trial in untreated patients with Waldenstroms Macroglobulinemia Symptomatic previously untreated patients will receive SOC bendamustine and rituximab for 6 28-day cycles Bendamustine will be given intravenously at 90 mgm2 on days 1 and 2 of each cycle Rituximab will be given on day 1 of each cycle 375 mgm2 intravenously for the first cycle and 1400 mg subcutaneously OR 375 mgm2 intravenously for subsequent cycles as per institutional procedures Concomitantly participants will receive 100 mg of the investigational product Acalabrutinib orally for 1 year 365 days at 100 mg BID
Detailed Description:
This is a multi-centre open label single-arm phase II clinical trial in untreated patients with WM Patients will require a biopsy to confirm the pathology and molecular testing for MYD88 CXCR4 and P53 mutations A bone marrow aspiration and biopsy will be performed to document WM and MRD Participants will be classified into clinical risk categories based on the International Prognostic Scoring IPS System for WM Symptomatic previously untreated patients will receive SOC bendamustine and rituximab for 6 28-day cycles Bendamustine will be given intravenously at 90 mgm2 on days 1 and 2 of each cycle Rituximab will be given on day 1 of each cycle 375 mgm2 intravenously for the first cycle and 1400 mg subcutaneously OR 375 mgm2 intravenously for subsequent cycles as per institutional procedures
Concomitantly participants will receive 100 mg of the investigational product Acalabrutinib orally for 1 year 365 days at 100 mg BID Patients will have pre-treatment computed tomography CT scans and CT scans at 7 12 and 18 months Best objective response will be documented using the criteria from the Sixth International Workshop on Waldenstroms Macroglobulinemia Assessment of metabolic uptake by positron emission tomography PET scan is not considered appropriate for WM as WM usually do not take up fluorodeoxyglucose FDG Patients with WM will also have disease assessed using measurements of serum IgM serum protein electrophoresis SPE immunofixation IFA and viscosity assessments measured serially A bone marrow aspiration and biopsy will be done before treatment and at response assessment at cycle 6 and will be repeated if positive Durability of response will also be assessed at 18 months
Participants will be followed by extended follow-up by telephone for up to 6 years to obtain data on the secondary endpoints
Concomitantly participants will receive 100 mg of the investigational product Acalabrutinib orally for 1 year 365 days at 100 mg BID Patients will have pre-treatment computed tomography CT scans and CT scans at 7 12 and 18 months Best objective response will be documented using the criteria from the Sixth International Workshop on Waldenstroms Macroglobulinemia Assessment of metabolic uptake by positron emission tomography PET scan is not considered appropriate for WM as WM usually do not take up fluorodeoxyglucose FDG Patients with WM will also have disease assessed using measurements of serum IgM serum protein electrophoresis SPE immunofixation IFA and viscosity assessments measured serially A bone marrow aspiration and biopsy will be done before treatment and at response assessment at cycle 6 and will be repeated if positive Durability of response will also be assessed at 18 months
Participants will be followed by extended follow-up by telephone for up to 6 years to obtain data on the secondary endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None