Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02296164
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2014-11-07
Brief Title:
Clinical Study Assessing Outcomes Adverse Events Treatment Patterns and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
Sponsor:
Helsinn Therapeutics US Inc
Organization:
Helsinn Therapeutics US Inc
Study Overview
Official Title:
A PROspective Observational US-based Study Assessing Outcomes Adverse Events Treatment Patterns and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma and Treated With Valchlor
Status:
COMPLETED
Status Verified Date:
2020-02
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:
PROVe
Brief Summary:
The Valchlor PROVe study is a multi-center prospective observational US-based drug study that longitudinally follows patients with Mycosis Fungoides Cutaneous T-cell Lymphoma MF-CTCL who are receiving therapy with Valchlor Patients will be followed prospectively for a maximum of 2 years from the date of signed informed consent enrollment until end of study Continuation in the study is not contingent on continuation of Valchlor
Detailed Description:
This is a multi-center prospective observational US-based drug study All consecutive Mycosis Fungoides Cutaneous T-cell Lymphoma MF-CTCL patients being treated with Valchlor will be invited to enroll in this studyPatients will undergo clinical assessments and receive standard medical care as determined by the patients physician in the real world setting With the exception of protocol-required patient completed questionnaires for symptoms and QOL there are no specific or mandated clinical assessments to be performed Patients will be followed prospectively for a maximum of 2 years
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