Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02729961
Status:
WITHDRAWN
Last Update Posted:
2019-10-10
First Post:
2016-03-29
Brief Title:
Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase III Open-Label Dose-Finding Study of Ceritinib Combined With Brentuximab Vedotin for Front-Line Treatment of ALK-Positive Anaplastic Large Cell Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative closure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial studies the side effects and best dose of ceritinib when given together with brentuximab vedotin to see how well they work in treating treatment-naive patients with anaplastic lymphoma kinase ALK-positive anaplastic large cell lymphoma Ceritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as brentuximab vedotin may interfere with the ability of tumor cells to grow and spread Giving ceritinib together with brentuximab vedotin may be a better treatment for ALK-positive anaplastic large cell lymphoma
Detailed Description:
PRIMARY OBJECTIVES I To define a dose of ceritinib administered concurrently with brentuximab vedotin that has an acceptable toxicity profile based on dose-limiting toxicity DLT rate and sufficient efficacy based on response rate among patients with treatment-naive ALK-positive anaplastic large cell lymphoma ALCL SECONDARY OBJECTIVES I To assess the antitumor activity of ceritinib and brentuximab vedotin combination in treatment-naive patients with ALK-positive ALCL II To assess the utility of the molecular marker of ALK-positive ALCL in patients plasma before during and after therapy for disease risk assessment and post-treatment monitoring OUTLINE This is a phase I dose-escalation study of ceritinib followed by a phase II study Patients receive brentuximab vedotin intravenously IV over 30 minutes on day 1 Patients also receive ceritinib orally PO once daily QD on days 8-21 of course 1 and on days 1-21 for all subsequent courses Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed up every 3 months up to 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 |
|---|---|---|---|
| NCI-2016-00396 | REGISTRY | None | None |
| 9522 | OTHER | None | None |
| P30CA015704 | NIH | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |