Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma

Purpose

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 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.

Condition

  • Mycosis Fungoides

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
MF-CTCL Patients receiving Valchlor 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 Quality Of Life.
  • Drug: Valchlor
    Valchlor gel 0.016%
    Other names:
    • Mechlorethamine gel

Recruiting Locations

More Details

NCT ID
NCT02296164
Status
Active, not recruiting
Sponsor
Helsinn Therapeutics (U.S.), Inc

Detailed Description

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 2 years