Observational US Study Assessing Outcomes, Treatment Patterns, AEs, QOL in MF-CTCL Patients and Treated With Valchlor
Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycosis Fungoides
Intervention: Valchlor (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Actelion Official(s) and/or principal investigator(s): Mitchell Nagao, PharmD, Study Director, Affiliation: Actelion Pharmaceuticals U.S., Inc.
Overall contact: Medical Information, Email: medinfo@actelion.com
Summary
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 1 year from the date of signed
informed consent (enrollment) until end of study. Continuation in the study is not
contingent on continuation of Valchlor.
Clinical Details
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®
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Population Descriptive
Secondary outcome: Patient self-reported questionnaires
Detailed description:
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 1 year
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Medical Information, Email: medinfo@actelion.com
Investigator Site, La Mesa, California 91941, United States; Recruiting Medical Information, Email: medinfo@actelion.com
Investigator Site, Coral Gables, Florida 33134, United States; Recruiting Medical Information, Email: medinfo@actelion.com
Investigator Site, Naples, Florida 34102, United States; Recruiting Medical Information, Email: medinfo@actelion.com
Investigator Site, Chicago, Illinois 60611, United States; Recruiting Medical Information, Email: medinfo@actelion.com
Investigator Site, Ann Arbor, Michigan 48103, United States; Recruiting Medical Information, Email: medinfo@actelion.com
Investigator Site, Exton, Pennsylvania 19341, United States; Recruiting Medical Information, Email: medinfo@actelion.com
Investigator Site, Philadelphia, Pennsylvania 19107, United States; Recruiting Medical Information, Email: medinfo@actelion.com
Investigator Site, Dallas, Texas 75231, United States; Recruiting Medical Information, Email: medinfo@actelion.com
Additional Information
Starting date: November 2014
Last updated: May 19, 2015
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