Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02677948
Status:
WITHDRAWN
Last Update Posted:
2017-09-06
First Post:
2016-02-04
Brief Title:
Multicenter Study of Pacritinib Combined With Ibrutinib in RelapsedRefractory Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase III Open Label Multicenter Study of Pacritinib Combined With Ibrutinib in RelapsedRefractory Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL
Status:
WITHDRAWN
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA has placed all trials involving Pacritinib on Full Clinical Hold
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study combines two drugs in the treatment of relapsedrefractory chronic lymphocytic leukemia CLL and small lymphocytic lymphoma SLL Investigators are proposing combining ibrutinib an orally-administered small molecule inhibitor of Brutons tyrosine kinase FDA approved for the treatment of relapsedrefractory CLL with pacritinib a novel JAK2-FLT3 inhibitor that has shown activity in relapsed lymphoma including CLLSLL Investigators will first demonstrate the safety and tolerability of Pacritinib when combined with Ibrutinib in a phase I study which will help establish the MTD Maximum Tolerated Doseof Pacritinib when combined with Ibrutinib Once the optimal dose of Pacritinib is established in the phase I setting a phase II evaluation will seek to establish the efficacy of the combination of Pacritinib with Ibrutinib Patients will receive continuous treatment until progressive disease and will be followed while on study treatment for a total of 2 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| HUM00105554 | OTHER | University of Michigan | None |