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®

SUMMARY

You are being asked to participate in this observational study named the PROVe study because you are either initiating therapy with commercial Valchlor® or you are currently treated with commercial Valchlor®, for the treatment of mycosis fungoides cutaneous T-cell lymphoma (MF-CTCL). The purpose of the PROVe study is to better understand the use of Valchlor® in clinical practice. Other goals include describing the demographic and clinical characteristics of the disease and health outcomes of patients treated with Valchlor®.

 

The PROVe study will collect information on approximately three hundred (300) patients either newly initiating or currently treated with Valchlor® at approximately fifty (50) sites in the United States. All patients taking Valchlor® will be invited to participate in the PROVe study. Data will be collected on patients for at least one (1) year, including retrospective data, if applicable (data from medical records that were recorded prior to start of the PROVe study), and follow-up clinic visit data. As this is an information-gathering study only, your doctor will manage your care no differently than he/she would if you were not part of this study program. You do not need to participate in the PROVe study to receive treatment for your condition.

The PROVe study will collect information on approximately three hundred (300) patients either newly initiating or currently treated with Valchlor® at approximately fifty (50) sites in the United States. All patients taking Valchlor® will be invited to participate in the PROVe study. Data will be collected on patients for at least one (1) year, including retrospective data, if applicable (data from medical records that were recorded prior to start of the PROVe study), and follow-up clinic visit data. As this is an information-gathering study only, your doctor will manage your care no differently than he/she would if you were not part of this study program. You do not need to participate in the PROVe study to receive treatment for your condition.

COH Protocol Number : 15157

ClinicalTrials.gov Number : NCT02296164

Principal Investigator : Querfeld, Christiane M.D., Ph.D

Sponsor : Actelion Pharmaceuticals US, INC

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : >=18

Gender : Either

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :