Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04765111
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2021-02-18
Brief Title:
Acalabrutinib and Rituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Acalabrutinib Plus Rituximab in Previously Untreated Elderly Patients With Mantle Cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 side effects of acalabrutinib and rituximab and its effect in treating patients with previously untreated mantle cell lymphoma Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Rituximab is a monoclonal antibody that binds to a protein called CD20 which is found on B-cells and may kill cancer cells Giving acalabrutinib and rituximab may help to control mantle cell lymphoma in elderly patients
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy measured by complete remission CR rate of the acalabrutinib in combination with rituximab in newly diagnosed elderly mantle cell lymphoma MCL patients
II To determine the safety profile of acalabrutinib with rituximab combination in elderly patients with MCL
SECONDARY OBJECTIVES
I To evaluate the overall response OR rate II To evaluate the progression-free survival and overall survival III To assess serial minimal residual disease MRD using clonoseq circulating tumor deoxyribonucleic acid ct-DNA based serial clonal evolution
IV Perform baseline genomic profiling for recognizing the predictive signature for response serial MCL specific analytes assessments while on therapy
EXPLORATORY OBJECTIVES
I Clonal evolution with targeted sequencing seq on ctDNA samples in sequential samples using a MCL specific customized gene panel would be assessed
II MRD assay using IgH clonoseq and ctDNA analysis flow cytometry at various time points from peripheral blood PBbone marrow BM
III Sequential immunologic studies with cytokineschemokines using a analyte panel T cell numbers and immunoglobulins Ig
IV Tissue microenvironmental studies with simultaneous assessment of PB BM and lymph nodes for gene expression profiling GEP single cell seq ribonucleic acid RNA seq and clonal heterogeneity and the impact of acalabrutinib A-rituximab R treatment
V Extensive bioinformatics studies VI Identification of signaling pathways or biomarkers that predict sensitivity after therapy
OUTLINE
Patients receive acalabrutinib orally PO twice daily BID on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive rituximab intravenously IV over 3-4 hours on days 1 8 15 and 22 of cycle 1 and day 1 of cycles 2-12 14 16 18 20 22 and 24 Cycles repeats every 28 days for up to 24 months or until complete remission is achieved in the absence of disease progression or unacceptable toxicity
After completion of study intervention patients are followed up at 30 days for 1 year every 4 months for 2 years every 6 months for 2 years and then annually for 3 years
I To determine the efficacy measured by complete remission CR rate of the acalabrutinib in combination with rituximab in newly diagnosed elderly mantle cell lymphoma MCL patients
II To determine the safety profile of acalabrutinib with rituximab combination in elderly patients with MCL
SECONDARY OBJECTIVES
I To evaluate the overall response OR rate II To evaluate the progression-free survival and overall survival III To assess serial minimal residual disease MRD using clonoseq circulating tumor deoxyribonucleic acid ct-DNA based serial clonal evolution
IV Perform baseline genomic profiling for recognizing the predictive signature for response serial MCL specific analytes assessments while on therapy
EXPLORATORY OBJECTIVES
I Clonal evolution with targeted sequencing seq on ctDNA samples in sequential samples using a MCL specific customized gene panel would be assessed
II MRD assay using IgH clonoseq and ctDNA analysis flow cytometry at various time points from peripheral blood PBbone marrow BM
III Sequential immunologic studies with cytokineschemokines using a analyte panel T cell numbers and immunoglobulins Ig
IV Tissue microenvironmental studies with simultaneous assessment of PB BM and lymph nodes for gene expression profiling GEP single cell seq ribonucleic acid RNA seq and clonal heterogeneity and the impact of acalabrutinib A-rituximab R treatment
V Extensive bioinformatics studies VI Identification of signaling pathways or biomarkers that predict sensitivity after therapy
OUTLINE
Patients receive acalabrutinib orally PO twice daily BID on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive rituximab intravenously IV over 3-4 hours on days 1 8 15 and 22 of cycle 1 and day 1 of cycles 2-12 14 16 18 20 22 and 24 Cycles repeats every 28 days for up to 24 months or until complete remission is achieved in the absence of disease progression or unacceptable toxicity
After completion of study intervention patients are followed up at 30 days for 1 year every 4 months for 2 years every 6 months for 2 years and then annually for 3 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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0858 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-00538 | REGISTRY | None | None |