Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783415
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2021-02-25
Brief Title:
Acalabrutinib Umbralisib and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase II Study of BTK Inhibitor Acalabrutinib and PI3Kδ Inhibitor Umbralisib in Combination With Ublituximab AU2 in Patients With Previously Untreated Mantle Cell Lymphoma MCL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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 phase II trial studies the effects of acalabrutinib umbralisib and ublituximab in treating previously untreated mantle cell lymphoma Acalabrutinib and umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Ublituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread Giving acalabrutinib and umbralisib with ublituximab may work better in treating mantle cell lymphoma
Detailed Description:
PRIMARY OBJECTIVE
I Evaluate the anti-tumor activity of acalabrutinib umbralisib and ublituximab AU2 regimen as induction therapy in patients with treatment-naïve mantle cell lymphoma MCL as assessed by the complete response CR rate
SECONDARY OBJECTIVES
I Evaluate the overall response rate ORR to AU2 in treatment-naive MCL II Evaluate the progression-free survival PFS overall survival OS and duration of response DOR in patients with treatment-naïve MCL who received AU2
III Evaluate the safety and tolerability of AU2 in patients with treatment-naive MCL
EXPLORATORY OBJECTIVES
I Examine the T-cell populations and functionality in patients treated with AU2
II Explore the predictive value of minimal residual disease MRD in MCL III Explore the mechanisms of resistance to AU2 therapy
OUTLINE
INDUCTION Patients receive ublituximab intravenously IV over 90 minutes-4 hours on days 1 8 and 15 of cycle 1 and days 1 of cycles 2-6 Patients also receive acalabrutinib orally PO twice daily BID and umbralisib PO once daily QD on days 1-28 Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE Patients receive ublituximab IV on day 1 on cycles 8 10 12 14 16 18 20 22 24 26 28 30 Patients also receive acalabrutinib Po BID and umbralisib PO QD on day 1-28 Treatment repeats every 28 days for 24 cycles in the absence of disease progression of unacceptable toxicity
After completion of study treatment patients are followed up for 30 days and then every 6 months for 2 years
I Evaluate the anti-tumor activity of acalabrutinib umbralisib and ublituximab AU2 regimen as induction therapy in patients with treatment-naïve mantle cell lymphoma MCL as assessed by the complete response CR rate
SECONDARY OBJECTIVES
I Evaluate the overall response rate ORR to AU2 in treatment-naive MCL II Evaluate the progression-free survival PFS overall survival OS and duration of response DOR in patients with treatment-naïve MCL who received AU2
III Evaluate the safety and tolerability of AU2 in patients with treatment-naive MCL
EXPLORATORY OBJECTIVES
I Examine the T-cell populations and functionality in patients treated with AU2
II Explore the predictive value of minimal residual disease MRD in MCL III Explore the mechanisms of resistance to AU2 therapy
OUTLINE
INDUCTION Patients receive ublituximab intravenously IV over 90 minutes-4 hours on days 1 8 and 15 of cycle 1 and days 1 of cycles 2-6 Patients also receive acalabrutinib orally PO twice daily BID and umbralisib PO once daily QD on days 1-28 Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE Patients receive ublituximab IV on day 1 on cycles 8 10 12 14 16 18 20 22 24 26 28 30 Patients also receive acalabrutinib Po BID and umbralisib PO QD on day 1-28 Treatment repeats every 28 days for 24 cycles in the absence of disease progression of unacceptable toxicity
After completion of study treatment patients are followed up for 30 days and then every 6 months for 2 years
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA033572 | NIH | City of Hope Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA033572 |
| NCI-2021-00498 | REGISTRY | None | None |
| 20459 | OTHER | None | None |