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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

Page last updated: August 23, 2015

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