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



Status:Active, not recruiting
Conditions:Infectious Disease, Lymphoma
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/26/2018
Start Date:November 12, 2014
End Date:September 1, 2020

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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®

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.

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

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
We found this trial at
31
sites
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New Haven, CT
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Ann Arbor, MI
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Boston, MA
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Charleston, South Carolina 29412
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Chicago, IL
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Cleveland, OH
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Coral Gables, FL
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Duarte, CA
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East Windsor, NJ
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Exton, PA
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Fairfax, VA
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42 Shannon Glen
Fairport, New York 14450
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Henderson, NV
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Hollywood, FL
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Jackson, MS
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Little Rock, AR
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Naples, FL
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Tampa, FL
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