Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
PROVe
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®
1 other identifier
observational
300
1 country
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2014
CompletedStudy Start
First participant enrolled
November 12, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2018
CompletedResults Posted
Study results publicly available
December 5, 2019
CompletedMarch 4, 2020
February 1, 2020
3.9 years
November 7, 2014
October 11, 2019
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
Valchlor gel 0.016%
Eligibility Criteria
Primary Care Clinic
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Investigator Site
Little Rock, Arkansas, 72205, United States
Investigator Site
Duarte, California, 91010, United States
Investigator Site
La Mesa, California, 91941, United States
Investigator Site
San Francisco, California, 94115, United States
Investigator Site
Santa Ana, California, 92701, United States
Investigator Site
Aurora, Colorado, 80045, United States
Investigator Site
New Haven, Connecticut, 06520, United States
Investigator Site
Coral Gables, Florida, 33134, United States
Investigator Site
Hollywood, Florida, 33021, United States
Investigator Site
Naples, Florida, 34102, United States
Investigator Site
Tampa, Florida, 33612, United States
Investigator Site
Atlanta, Georgia, 30328, United States
Investigator Site
Chicago, Illinois, 60611, United States
Investigator Site
Chicago, Illinois, 60612, United States
Investigator Site
Chicago, Illinois, 60637, United States
Investigator Site
New Orleans, Louisiana, 70112, United States
Investigator Site
Boston, Massachusetts, 02215, United States
Investigator Site
Ann Arbor, Michigan, 48103, United States
Investigator Site
Jackson, Mississippi, 39216, United States
Investigator Site
St Louis, Missouri, 63104, United States
Investigator Site
St Louis, Missouri, 63110, United States
Investigator Site
Henderson, Nevada, 89074, United States
Investigator Site
East Windsor, New Jersey, 08520, United States
Investigator Site
Brooklyn, New York, 11203, United States
Investigator Site
Fairport, New York, 14450, United States
Investigator Site
New York, New York, 10032, United States
Investigator Site
The Bronx, New York, 10467, United States
Investigator Site
Cleveland, Ohio, 44106, United States
Investigator Site
Exton, Pennsylvania, 19341, United States
Investigator Site
Philadelphia, Pennsylvania, 19104, United States
Investigator Site
Philadelphia, Pennsylvania, 19107, United States
Investigator Site
Pittsburgh, Pennsylvania, 15213, United States
Investigator Site
Charleston, South Carolina, 29414, United States
Investigator Site
Dallas, Texas, 75231, United States
Investigator Site
Dallas, Texas, 75390, United States
Investigator Site
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bill Bailey
- Organization
- Helsinn Therapeutics (U.S.), Inc.
Study Officials
- STUDY DIRECTOR
Bill Bailey
Helsinn Therapeutics (U.S.), Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2014
First Posted
November 20, 2014
Study Start
November 12, 2014
Primary Completion
October 17, 2018
Study Completion
October 17, 2018
Last Updated
March 4, 2020
Results First Posted
December 5, 2019
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share
observational study