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 ]

demographics and clinical characteristics treatment patterns, clinical status as assessed by the physician (and the methods used in practice to assess clinical status), MF-CTCL-related healthcare utilization, as assessed by the physician (hospitalizations and emergency room visits), AEs and SAEs (e.g., dermatitis), in 300 patients


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient self-reported questionnaires [ Time Frame: 1 year ]

patient-completed symptoms and QOL questionnaires comparisons are intended to assess burden of disease in a Valchlor-treated cohort over time.


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