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.
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 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 2 years
Study Type
OBSERVATIONAL
Enrollment
300
Valchlor gel 0.016%
Investigator Site
Little Rock, Arkansas, United States
Investigator Site
Duarte, California, United States
Investigator Site
La Mesa, California, United States
Investigator Site
San Francisco, California, United States
Investigator Site
Santa Ana, California, United States
Investigator Site
Treatment Responders Using Body Surface Area (BSA) at 12 Months
The primary efficacy endpoint was the proportion of patients who are responders to treatment at the 12-month timepoint using a ≥50% reduction from baseline in BSA as the definition of a responder in the group of patients who used mechlorethamine plus corticosteroids and possibly another treatment.
Time frame: 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aurora, Colorado, United States
Investigator Site
New Haven, Connecticut, United States
Investigator Site
Coral Gables, Florida, United States
Investigator Site
Hollywood, Florida, United States
Investigator Site
Naples, Florida, United States
...and 26 more locations