Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644183
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Roginolisib IOA-244 With Venetoclax and Rituximab for RefractoryRelapsed Chronic Lymphocytic Leukemia CLL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12 Open Label Study of Roginolisib IOA-244 an Orally Bioavailable Selective PI3Kδ Inhibitor in Patients With RefractoryRelapsed Chronic Lymphocytic Leukemia CLL in Combination With Venetoclax and Rituximab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study will test the safety and anticancer activity of the combination of three drugs Roginolisib Venetoclax and Rituximab for participants with relapsed or refractory Chronic Lymphocytic Leukemia CLL
The names of the study drugs involved in this study are
Roginolisib a novel type of PI3-kinase delta inhibitor
Venetoclax a type of B-cell lymphoma 2 inhibitor
Rituximab a type of monoclonal antibody
The names of the study drugs involved in this study are
Roginolisib a novel type of PI3-kinase delta inhibitor
Venetoclax a type of B-cell lymphoma 2 inhibitor
Rituximab a type of monoclonal antibody
Detailed Description:
This is a Phase III open-label randomized and comparator controlled study to test the safety and anticancer activity of the combination of three drugs Roginolisib Venetoclax and Rituximab for participants with relapsed or refractory Chronic Lymphocytic Leukemia CLL In this study investigators are assessing whether adding the study drug Roginolisib will lead to deeper responses than the standard combination of Venetoclax and Rituximab alone
A phase Ib safety lead-in portion of the trial will determine the dose and tolerability of Roginolisib with the standard 2-drug combination treatment of Venetoclax Rituximab
In the phase 2 portion of the trial participants will be randomized into one of two treatment arms Arm A Roginolisib Venetoclax and Rituximab vs Arm B Venetoclax and Rituximab Randomization means a participant is placed into a treatment arm by chance
The US Food and Drug Administration FDA has not approved Roginolisib as a treatment for relapsed or refractory CLL
The US FDA has approved Venetoclax and Rituximab as a standard 2-drug combination treatment for relapsed or refractory CLL
The research study procedures include screening for eligibility in-clinic visits blood tests urine tests electrocardiograms ECGs Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans and bone marrow biopsy andor aspirations
Participants will receive study treatment for approximately 12 months and will be followed for up to 5 years
It is expected about 3-12 people will take part in the Phase 1 portion of the trial and 52 people will participate in the Phase 2 portion of the research study
iOnctura SA is supporting this research study by providing the study drug Roginolisib
The US Department of Defense DOD is supporting this research study by providing funding
A phase Ib safety lead-in portion of the trial will determine the dose and tolerability of Roginolisib with the standard 2-drug combination treatment of Venetoclax Rituximab
In the phase 2 portion of the trial participants will be randomized into one of two treatment arms Arm A Roginolisib Venetoclax and Rituximab vs Arm B Venetoclax and Rituximab Randomization means a participant is placed into a treatment arm by chance
The US Food and Drug Administration FDA has not approved Roginolisib as a treatment for relapsed or refractory CLL
The US FDA has approved Venetoclax and Rituximab as a standard 2-drug combination treatment for relapsed or refractory CLL
The research study procedures include screening for eligibility in-clinic visits blood tests urine tests electrocardiograms ECGs Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans and bone marrow biopsy andor aspirations
Participants will receive study treatment for approximately 12 months and will be followed for up to 5 years
It is expected about 3-12 people will take part in the Phase 1 portion of the trial and 52 people will participate in the Phase 2 portion of the research study
iOnctura SA is supporting this research study by providing the study drug Roginolisib
The US Department of Defense DOD is supporting this research study by providing funding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None