Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT04624633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-27
First Post:
2020-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL
Sponsor:
Jennifer R. Brown, MD, PhD
Organization:
Study Overview
Official Title:
A Phase 2 Study of Acalabrutinib, Umbralisib, and Ublituximab (AU2) in Relapsed and Previously Untreated CLL Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
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:
This study is testing the effectiveness of the study drug combination of acalabrutinib, umbralisib, and ublituximab in participants with Chronic Lymphocytic leukemia (CLL).
The names of the study drugs involved in this study are/is:
* Acalabrutinib (CALQUENCE®, ACP-196)
* Umbralisib (TGR-1202)
* Ublituximab (TG-1101)
The names of the study drugs involved in this study are/is:
* Acalabrutinib (CALQUENCE®, ACP-196)
* Umbralisib (TGR-1202)
* Ublituximab (TG-1101)
Detailed Description:
In this research study, Investigators are exploring the combination of acalabrutinib, umbralisib, and ublituximab and hoping to determine if the combination is effective at controlling cancer growth in participants with CLL.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive the study drugs for a maximum of 24 cycles (2 years) and will be followed for a maximum of 5 years after discontinuing the study drugs.
The names of the study drugs involved in this study are/is:
* Acalabrutinib (CALQUENCE®, ACP-196)
* Umbralisib (TGR-1202)
* Ublituximab (TG-1101)
It is expected that about 60 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 drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied.
* The U.S. Food and Drug Administration (FDA) has not approved umbralisib or ublituximab as a treatment for any disease.
* The U.S. Food and Drug Administration (FDA) has approved acalabrutinib for CLL, but not in this combination.
* Acalabrutinib is a type of drug called a kinase inhibitor. It blocks a type of protein called Bruton Tyrosine Kinase (BTK) that helps CLL cells live and grow. By blocking BTK, acalabrutinib may kill cancer cells or stop them from growing.
* Umbralisib is an investigational drug which blocks a protein called PI3K. PI3K is a protein that helps CLL cells grow.
* Ublituximab is a type of investigational drug called a monoclonal antibody. A monoclonal antibody is a type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. By binding to the tumor cells, the antibody might prevent the tumor cell from growing and spreading.
As of March 2023, TG therapeutics has decided to no longer provide umbralisib, ublituximab and funding for this study. Study participants still on treatment will still have access to acalabrutinib.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive the study drugs for a maximum of 24 cycles (2 years) and will be followed for a maximum of 5 years after discontinuing the study drugs.
The names of the study drugs involved in this study are/is:
* Acalabrutinib (CALQUENCE®, ACP-196)
* Umbralisib (TGR-1202)
* Ublituximab (TG-1101)
It is expected that about 60 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 drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied.
* The U.S. Food and Drug Administration (FDA) has not approved umbralisib or ublituximab as a treatment for any disease.
* The U.S. Food and Drug Administration (FDA) has approved acalabrutinib for CLL, but not in this combination.
* Acalabrutinib is a type of drug called a kinase inhibitor. It blocks a type of protein called Bruton Tyrosine Kinase (BTK) that helps CLL cells live and grow. By blocking BTK, acalabrutinib may kill cancer cells or stop them from growing.
* Umbralisib is an investigational drug which blocks a protein called PI3K. PI3K is a protein that helps CLL cells grow.
* Ublituximab is a type of investigational drug called a monoclonal antibody. A monoclonal antibody is a type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. By binding to the tumor cells, the antibody might prevent the tumor cell from growing and spreading.
As of March 2023, TG therapeutics has decided to no longer provide umbralisib, ublituximab and funding for this study. Study participants still on treatment will still have access to acalabrutinib.
Study Oversight
Has Oversight DMC:
True
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?: