Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT04906902
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2021-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acalabrutinib in CNSL
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase 1/2 Study of Acalabrutinib in Recurrent or Refractory Central Nervous System Lymphoma (CNSL)
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is a Phase 1/2 clinical trial testing the safety, tolerance and efficacy of the drug Acalabrutinib for people with recurrent or refractory central nervous system lymphoma (CNSL).
Detailed Description:
This is an open-label, dose-escalation phase 1/2 study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of Acalabrutinib in patients with recurrent or refractory CNS lymphoma (R/R CNSL).
Acalabrutinib has been studied in lab experiments and in other types of cancer, and information from these studies suggests that acalabrutinib may be beneficial for people with recurrent or refractory central nervous system lymphoma (CNSL). Acalabrutinib targets a vulnerable part of cancer cells which leads to an inhibition of the growth of cancer cells.
The U.S. Food and Drug Administration (FDA) has not approved acalabrutinib for recurrent or refractory central nervous system lymphoma (CNSL) but it has been approved for other uses.
The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive study treatment for up to 2 years as long as they do not have serious side effects and their disease does not get worse.
Approximately 15 to 21 participants will be enrolled in phase1 and approximately 28 patients will be enrolled Phase 2.
AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and the study drug, acalabrutinib.
Acalabrutinib has been studied in lab experiments and in other types of cancer, and information from these studies suggests that acalabrutinib may be beneficial for people with recurrent or refractory central nervous system lymphoma (CNSL). Acalabrutinib targets a vulnerable part of cancer cells which leads to an inhibition of the growth of cancer cells.
The U.S. Food and Drug Administration (FDA) has not approved acalabrutinib for recurrent or refractory central nervous system lymphoma (CNSL) but it has been approved for other uses.
The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive study treatment for up to 2 years as long as they do not have serious side effects and their disease does not get worse.
Approximately 15 to 21 participants will be enrolled in phase1 and approximately 28 patients will be enrolled Phase 2.
AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and the study drug, acalabrutinib.
Study Oversight
Has Oversight DMC:
True
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?: