Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01789723
Status:
WITHDRAWN
Last Update Posted:
2020-01-23
First Post:
2013-02-07
Brief Title:
Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkins Lymphoma Receiving Folotyn
Sponsor:
Acrotech Biopharma Inc
Organization:
Acrotech Biopharma Inc
Study Overview
Official Title:
An Open Label Multicenter Dose Finding Phase 1 Study of Fusilev Levoleucovorin to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma Receiving Folotyn Pralatrexate
Status:
WITHDRAWN
Status Verified Date:
2020-01
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:
The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkins Lymphoma receiving Folotyn treatment
Detailed Description:
This is an open label uncontrolled nonrandomized multicenter dose finding Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral Mucositis
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