Clinical trial NCT02296164: Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycosis Fungoides
Keywords: PROVe
CTCL
Mechlorethamine
Cutaneous T-cell lymphoma
Mycosis fungoides cutaneous T-cell lymphoma
Valchlor
Dermatology
MF-CTCL
Mycosis Fungoides
Oncology
Lead sponsor: Helsinn Therapeutics (U.S.), Inc
Sponsor class: INDUSTRY
First posted: 2014-11-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.

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

Eligibility 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

Primary outcomes:
measure: Treatment Responders Using Body Surface Area (BSA) at 12 Months
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Investigator Site
state: Arkansas
city: Duarte
country: United States
facility: Investigator Site
state: California
city: La Mesa
country: United States
facility: Investigator Site
state: California
city: San Francisco
country: United States
facility: Investigator Site
state: California
city: Santa Ana
country: United States
facility: Investigator Site
state: California
city: Aurora
country: United States
facility: Investigator Site
state: Colorado
city: New Haven
country: United States
facility: Investigator Site
state: Connecticut
city: Coral Gables
country: United States
facility: Investigator Site
state: Florida
city: Hollywood
country: United States
facility: Investigator Site
state: Florida
city: Naples
country: United States
facility: Investigator Site
state: Florida
city: Tampa
country: United States
facility: Investigator Site
state: Florida
city: Atlanta
country: United States
facility: Investigator Site
state: Georgia
city: Chicago
country: United States
facility: Investigator Site
state: Illinois
city: Chicago
country: United States
facility: Investigator Site
state: Illinois
city: Chicago
country: United States
facility: Investigator Site
state: Illinois
city: New Orleans
country: United States
facility: Investigator Site
state: Louisiana
city: Boston
country: United States
facility: Investigator Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Investigator Site
state: Michigan
city: Jackson
country: United States
facility: Investigator Site
state: Mississippi
city: Saint Louis
country: United States
facility: Investigator Site
state: Missouri
city: Saint Louis
country: United States
facility: Investigator Site
state: Missouri
city: Henderson
country: United States
facility: Investigator Site
state: Nevada
city: East Windsor
country: United States
facility: Investigator Site
state: New Jersey
city: Bronx
country: United States
facility: Investigator Site
state: New York
city: Brooklyn
country: United States
facility: Investigator Site
state: New York
city: Fairport
country: United States
facility: Investigator Site
state: New York
city: New York
country: United States
facility: Investigator Site
state: New York
city: Cleveland
country: United States
facility: Investigator Site
state: Ohio
city: Exton
country: United States
facility: Investigator Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigator Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigator Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigator Site
state: Pennsylvania
city: Charleston
country: United States
facility: Investigator Site
state: South Carolina
city: Dallas
country: United States
facility: Investigator Site
state: Texas
city: Dallas
country: United States
facility: Investigator Site
state: Texas
city: Fairfax
country: United States
facility: Investigator Site
state: Virginia
Study officials:
affiliation: Helsinn Therapeutics (U.S.), Inc
name: Bill Bailey
role: STUDY_DIRECTOR
References: