Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836832
Status:
WITHDRAWN
Last Update Posted:
2022-06-07
First Post:
2021-03-09
Brief Title:
Acalabrutinib and Duvelisib for the Treatment of RelapsedRefractory Indolent Non-Hodgkin Lymphoma
Sponsor:
Narendranath Epperla
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase IbII Study of Duvelisib and Acalabrutinib in RelapsedRefractory Indolent Non-Hodgkin Lymphoma DUAL Trial
Status:
WITHDRAWN
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI decision
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IbII trial studies the side effects of acalabrutinib and duvelisib and how well they work in treating patients with indolent non-Hodgkin lymphoma that has come back relapsed or does not respond to treatment refractory Acalabrutinib inhibits a signaling molecule called Bruton tyrosine kinase and blocks cancer cell proliferation growth and survival Duvelisib is designed to block a protein called PI3 kinase in order to stop cancer growth and cause changes in the immune system that may allow the immune system to better act against cancer cells Giving acalabrutinib and duvelisib together may work better to block cancer growth than therapy of either drug alone
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety and tolerability of the combination of acalabrutinib and duvelisib in patients with relapsed or refractory indolent non-Hodgkin lymphoma iNHL
II Determine maximum tolerated dose MTD and recommended phase 2 dose RP2D III To estimate the overall response rate ORR Lugano 2014 computed tomography CT based of acalabrutinib in combination with duvelisib at 6 months in follicular lymphoma FL and marginal zone lymphoma MZL cohorts
SECONDARY OBJECTIVES
I To evaluate the activity of acalabrutinib and duvelisib as measured by ORR based on positron emission tomography PET scan at 6 months duration of response DOR and 2-year progression-free survival PFS
II To capture patient-reported outcomes PROs
EXPLORATORY OBJECTIVE
I To determine the correlation of the clinical activity of acalabrutinib in combination with duvelisib with established biomarkers and identify putative novel markers
OUTLINE This is a phase Ib dose-escalation study of duvelisib followed by a phase II study
Patients receive acalabrutinib orally PO twice daily BID and duvelisib PO BID on days 1-28 Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Beginning cycle 19 patients receive acalabrutinib PO BID for up to 60 months in absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3 months thereafter
I To assess the safety and tolerability of the combination of acalabrutinib and duvelisib in patients with relapsed or refractory indolent non-Hodgkin lymphoma iNHL
II Determine maximum tolerated dose MTD and recommended phase 2 dose RP2D III To estimate the overall response rate ORR Lugano 2014 computed tomography CT based of acalabrutinib in combination with duvelisib at 6 months in follicular lymphoma FL and marginal zone lymphoma MZL cohorts
SECONDARY OBJECTIVES
I To evaluate the activity of acalabrutinib and duvelisib as measured by ORR based on positron emission tomography PET scan at 6 months duration of response DOR and 2-year progression-free survival PFS
II To capture patient-reported outcomes PROs
EXPLORATORY OBJECTIVE
I To determine the correlation of the clinical activity of acalabrutinib in combination with duvelisib with established biomarkers and identify putative novel markers
OUTLINE This is a phase Ib dose-escalation study of duvelisib followed by a phase II study
Patients receive acalabrutinib orally PO twice daily BID and duvelisib PO BID on days 1-28 Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Beginning cycle 19 patients receive acalabrutinib PO BID for up to 60 months in absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3 months thereafter
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-01355 | REGISTRY | CTRP Clinical Trial Reporting Program | None |