Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
Study NCT ID:
NCT04189757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2019-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Study of Acalabrutinib in Ibrutinib-Intolerant Mantle Cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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 how well acalabrutinib works in treating patients with mantle cell lymphoma that cannot tolerate ibrutinib. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess the overall response rate (ORR) at the end of 3 cycles of acalabrutinib.
SECONDARY OBJECTIVES:
I. To assess the proportion of patients that are progression free without any of the following toxicities at the end of 3 cycles:
Ia. Recurrence of intolerable toxicities previously noted on ibrutinib. Ib. The occurrence of intolerable toxicities related to acalabrutinib defined as: grade 4 neutropenia or thrombocytopenia lasting greater than 7 days or any grade \>= 3 non-hematologic toxicity as assessed by the investigator to be related to study drug).
II. To determine the efficacy of acalabrutinib, progression free survival (PFS) and duration of response (DOR) in patients.
III. To assess the safety profile of acalabrutinib in patient's intolerant to ibrutinib.
EXPLORATORY OBJECTIVE:
I. Sequential peripheral blood (PB)/plasma/tissue fine-needle aspiration (FNA) will be stored for evaluation of:
Ia. Clonal evolution with targeted sequencing (seq) and/or whole exome sequencing (WES) in sequential samples.
Ib. Pattern of mutation changes with acalabrutinib. Ic. Response predictors - mutations, cytokine-chemokines. Id. Minimal residual disease (MRD) assay using flow cytometry (FC) and circulating tumor-derived deoxyribonucleic acid (ctDNA) analysis.
Ie. Sequential immunologic studies with cytokines/chemokines, T cells and immunoglobulins.
OUTLINE:
Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 1 years, then annually for up to 3 years.
I. To assess the overall response rate (ORR) at the end of 3 cycles of acalabrutinib.
SECONDARY OBJECTIVES:
I. To assess the proportion of patients that are progression free without any of the following toxicities at the end of 3 cycles:
Ia. Recurrence of intolerable toxicities previously noted on ibrutinib. Ib. The occurrence of intolerable toxicities related to acalabrutinib defined as: grade 4 neutropenia or thrombocytopenia lasting greater than 7 days or any grade \>= 3 non-hematologic toxicity as assessed by the investigator to be related to study drug).
II. To determine the efficacy of acalabrutinib, progression free survival (PFS) and duration of response (DOR) in patients.
III. To assess the safety profile of acalabrutinib in patient's intolerant to ibrutinib.
EXPLORATORY OBJECTIVE:
I. Sequential peripheral blood (PB)/plasma/tissue fine-needle aspiration (FNA) will be stored for evaluation of:
Ia. Clonal evolution with targeted sequencing (seq) and/or whole exome sequencing (WES) in sequential samples.
Ib. Pattern of mutation changes with acalabrutinib. Ic. Response predictors - mutations, cytokine-chemokines. Id. Minimal residual disease (MRD) assay using flow cytometry (FC) and circulating tumor-derived deoxyribonucleic acid (ctDNA) analysis.
Ie. Sequential immunologic studies with cytokines/chemokines, T cells and immunoglobulins.
OUTLINE:
Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 1 years, then annually for up to 3 years.
Study Oversight
Has Oversight DMC:
False
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?: