Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05065554
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2021-09-20
Brief Title:
ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy
Sponsor:
Shayna Sarosiek MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study on Acalabrutinib and Anti-CD20 Antibody in Patients With Predominantly Demyelinating Neuropathy With or Without Anti-MAG
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
In this research study is combining a new treatment acalabrutinib with a standard treatment rituximab or other CD20 antibody to determine whether this combination is safe and effective for participants with Immunoglobulin Ig M monoclonal gammopathy of undetermined significance IgM MGUS or Waldenström macroglobulinemia WM related neuropathies
The names of the study drugs involved in this study areis
Acalabrutinib
Rituximab or similar CD20 antibody
The names of the study drugs involved in this study areis
Acalabrutinib
Rituximab or similar CD20 antibody
Detailed Description:
This research study involves an experimental drug combination of a targeted therapy and a CD20 antibody
The names of the study drugs involved in this study areis
Acalabrutinib
Rituximab or similar CD20 antibody
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
The study treatment for up to 4 years and will be followed for 2 years after completion of study treatment
It is expected that about 33 people will take part in this research study
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved acalabrutinib for this specific disease but it has been approved for other uses
The US Food and Drug Administration FDA has not approved rituximab or similar CD20 antibody for this specific disease but it has been approved for other uses
Acalabrutinib is a targeted therapy that blocks a type of protein called Bruton Tyrosine Kinase BTK that helps cells live and grow By blocking BTK acalabrutinib may kill abnormal cells or stop them from growing It has been FDA approved for mantle cell lymphoma MCL
Rituximab or biosimilar is a type of therapy called an antibody that attacks CD20 a protein found on B-cells Rituximab is approved by the FDA for treating non-Hodgkin lymphoma NHL Rituximab is often used to treat WM and IgM MGUS neuropathies Biosimilars are FDA approved drugs that have been determined to be interchangeable with the original drug
The names of the study drugs involved in this study areis
Acalabrutinib
Rituximab or similar CD20 antibody
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
The study treatment for up to 4 years and will be followed for 2 years after completion of study treatment
It is expected that about 33 people will take part in this research study
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved acalabrutinib for this specific disease but it has been approved for other uses
The US Food and Drug Administration FDA has not approved rituximab or similar CD20 antibody for this specific disease but it has been approved for other uses
Acalabrutinib is a targeted therapy that blocks a type of protein called Bruton Tyrosine Kinase BTK that helps cells live and grow By blocking BTK acalabrutinib may kill abnormal cells or stop them from growing It has been FDA approved for mantle cell lymphoma MCL
Rituximab or biosimilar is a type of therapy called an antibody that attacks CD20 a protein found on B-cells Rituximab is approved by the FDA for treating non-Hodgkin lymphoma NHL Rituximab is often used to treat WM and IgM MGUS neuropathies Biosimilars are FDA approved drugs that have been determined to be interchangeable with the original drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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