Ignite Creation Date:
2024-05-06 @ 12:16 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03719898
Status:
WITHDRAWN
Last Update Posted:
2021-01-05
First Post:
2018-10-16
Brief Title:
Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Study of Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
FDA approved drugs to treat patients with relapsed or refractory anaplastic large cell lymphoma ALCL has a median progression free survival of 20 months Majority of patients relapse in 2 years This study will evaluate overall response rate of next generation ALK inhibitor brigatinib in ALK positive ALCL patients by overcoming mechanisms of resistance to ALK inhibitors on cancer patients
Detailed Description:
Although patients with ALK anaplastic large cell lymphoma ALCL a type of peripheral T-cell lymphoma PTCL are considered to have a favorable prognosis relapse is not uncommon if multiple International Prognostic Index IPI risk factors age 40 and beta-2 microglobulin 3 mgL are present at diagnosis For patients older than 40 years at diagnosis and beta-2 microglobulin 3 mgL progression-free survival PFS and overall survival OS is less than 50 at 25 years when treated with standard anthracycline-based induction therapy Patients with ALK ALCL with 3 or more IPI risk factors have a 5-year PFS rate of only 20 to 30 In total approximately 40 to 65 of patients with ALCL develop recurrent disease after front-line chemotherapy and at relapse the disease is historically resistant to conventional chemotherapy
Current FDA approved for treatment of relapsed or refractory PTCLs have a median PFS of 20 months and majority of patients relapse within 2 years Despite ALK tyrosine kinase being an attractive target for management of relapsed or refractory ALK ALCL ALK gene rearrangement makes cancer resistant to first and 2nd generation ALK inhibitors Brigatinib is a next generation inhibitor with broad activity aganst a broad spetrum of resistant ALK mutants Brigatinib has been shown to overcome mechanisms associated with resistane to 1st and 2nd generation ALK inhibitors It is approved as 2nd line of treament in non small cell lung cancer patients and is being tested in patients with relapsed or refractory ALK-positive ALCL
Current FDA approved for treatment of relapsed or refractory PTCLs have a median PFS of 20 months and majority of patients relapse within 2 years Despite ALK tyrosine kinase being an attractive target for management of relapsed or refractory ALK ALCL ALK gene rearrangement makes cancer resistant to first and 2nd generation ALK inhibitors Brigatinib is a next generation inhibitor with broad activity aganst a broad spetrum of resistant ALK mutants Brigatinib has been shown to overcome mechanisms associated with resistane to 1st and 2nd generation ALK inhibitors It is approved as 2nd line of treament in non small cell lung cancer patients and is being tested in patients with relapsed or refractory ALK-positive ALCL
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 |
|---|---|---|---|
| 18-1032 | OTHER | Fox Chase Cancer Center | None |