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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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®

Conditions
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Mycosis Fungoides

Intervention / Treatment
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* Drug: Valchlor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MF-CTCL Patients receiving Valchlor<br>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<br>* Valchlor gel 0.016%<br>* Other names: Mechlorethamine gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PROVe, CTCL, Mechlorethamine, Cutaneous T-cell lymphoma, Mycosis fungoides cutaneous T-cell lymphoma, Valchlor, Dermatology, MF-CTCL, Mycosis Fungoides, Oncology