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

Mycosis Fungoides Clinical Trial

— PROVe  

Official 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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296164
• Other study ID #: AC-079A501
• Status: Completed
• Start date: November 12, 2014
• Est. completion date: October 17, 2018

Study information

• Verified date: February 2020
• Source: Helsinn Therapeutics (U.S.), Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 17, 2018
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides

Intervention

Drug:
• Valchlor
Valchlor gel 0.016%

Locations

Country	Name	City	State
United States	Investigator Site	Ann Arbor	Michigan
United States	Investigator Site	Atlanta	Georgia
United States	Investigator Site	Aurora	Colorado
United States	Investigator Site	Boston	Massachusetts
United States	Investigator Site	Bronx	New York
United States	Investigator Site	Brooklyn	New York
United States	Investigator Site	Charleston	South Carolina
United States	Investigator Site	Chicago	Illinois
United States	Investigator Site	Chicago	Illinois
United States	Investigator Site	Chicago	Illinois
United States	Investigator Site	Cleveland	Ohio
United States	Investigator Site	Coral Gables	Florida
United States	Investigator Site	Dallas	Texas
United States	Investigator Site	Dallas	Texas
United States	Investigator Site	Duarte	California
United States	Investigator Site	East Windsor	New Jersey
United States	Investigator Site	Exton	Pennsylvania
United States	Investigator Site	Fairfax	Virginia
United States	Investigator Site	Fairport	New York
United States	Investigator Site	Henderson	Nevada
United States	Investigator Site	Hollywood	Florida
United States	Investigator Site	Jackson	Mississippi
United States	Investigator Site	La Mesa	California
United States	Investigator Site	Little Rock	Arkansas
United States	Investigator Site	Naples	Florida
United States	Investigator Site	New Haven	Connecticut
United States	Investigator Site	New Orleans	Louisiana
United States	Investigator Site	New York	New York
United States	Investigator Site	Philadelphia	Pennsylvania
United States	Investigator Site	Philadelphia	Pennsylvania
United States	Investigator Site	Pittsburgh	Pennsylvania
United States	Investigator Site	Saint Louis	Missouri
United States	Investigator Site	Saint Louis	Missouri
United States	Investigator Site	San Francisco	California
United States	Investigator Site	Santa Ana	California
United States	Investigator Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Helsinn Therapeutics (U.S.), Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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