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

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.

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Key information

Conditions

Mycosis Fungoides Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigator Site, Little Rock, Arkansas, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valchlor

Drug

Valchlor gel 0.016%

Other names: Mechlorethamine gel

Primary outcomes

Treatment Responders Using Body Surface Area (BSA) at 12 Months

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helsinn Therapeutics (U.S.), Inc

Industry

Registry information

Official study title

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®

Acronym: PROVe

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Nov 20, 2014
Registry last updated: Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting