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
    Recruiting
  • sponsor
    Actelion
Updated on 23 November 2020

Summary

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®

Description

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.

Protocol #: AC-079A501

Details
Clinical Study IdentifierTX141982
SponsorActelion
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
All adult patients (≥ 18 years of age) diagnosed with MF CTCL and being treated with Valchlor. This includes patients newly initiating Valchlor OR patients continuing treatment with Valchlor
Patients newly initiating Valchlor are patients who have their first office visit after having initiated Valchlor
Patients continuing treatment with Valchlor includes patients who are actively taking Valchlor on the day of enrollment
Signed patient informed consent

Exclusion Criteria

None
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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