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

February 21, 2020 updated by: Helsinn Therapeutics (U.S.), Inc

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Investigator Site
    • California
      • Duarte, California, United States, 91010
        • Investigator Site
      • La Mesa, California, United States, 91941
        • Investigator Site
      • San Francisco, California, United States, 94115
        • Investigator Site
      • Santa Ana, California, United States, 92701
        • Investigator Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Investigator Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Investigator Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Investigator Site
      • Hollywood, Florida, United States, 33021
        • Investigator Site
      • Naples, Florida, United States, 34102
        • Investigator Site
      • Tampa, Florida, United States, 33612
        • Investigator Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Investigator Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Investigator Site
      • Chicago, Illinois, United States, 60612
        • Investigator Site
      • Chicago, Illinois, United States, 60637
        • Investigator Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Investigator Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Investigator Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Investigator Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Investigator Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Investigator Site
      • Saint Louis, Missouri, United States, 63104
        • Investigator Site
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Investigator Site
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Investigator Site
    • New York
      • Bronx, New York, United States, 10467
        • Investigator Site
      • Brooklyn, New York, United States, 11203
        • Investigator Site
      • Fairport, New York, United States, 14450
        • Investigator Site
      • New York, New York, United States, 10032
        • Investigator Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Investigator Site
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • Investigator Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigator Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Investigator Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Investigator Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Investigator Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Investigator Site
      • Dallas, Texas, United States, 75390
        • Investigator Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary Care Clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinn Therapeutics (U.S.), Inc

Investigators

  • Study Director: Bill Bailey, Helsinn Therapeutics (U.S.), Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2014

Primary Completion (Actual)

October 17, 2018

Study Completion (Actual)

October 17, 2018

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-079A501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

observational study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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