Clinical Trial: Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: A PROspective, Observational, US-based Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutan
Brief Summary: The Valchlor PROVe study is a multi-center, prospective, observational, US-based drug study that longitudinally follows patients with MF-CTCL who are receiving therapy with Valchlor. Patients will be followed prospectively for a maximum of 1 year from the date of signed informed consent (enrollment) until end of study. Continuation in the study is not contingent on continuation of Valchlor.
Detailed Summary: This is a multi-center, prospective, observational, US-based drug study. All consecutive MF-CTCL patients being treated with Valchlor will be invited to enroll in this study.Patients 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 1 year
Sponsor: Actelion
Current Primary Outcome: Population Descriptive [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient self-reported questionnaires [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Actelion
Dates:
Date Received: November 7, 2014
Date Started: November 2014
Date Completion: March 2018
Last Updated: November 18, 2016
Last Verified: November 2016