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Alkylating agents
Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma (PROVe Trial)
Little Rock, AR
N/A
Waitlist Available
Research Sponsored by Helsinn Therapeutics (U.S.), Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
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.
Eligible Conditions
- Cutaneous T-Cell Lymphoma
- Mycosis Fungoides
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment Responders Using Body Surface Area (BSA) at 12 Months
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MF-CTCL Patients receiving ValchlorExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mechlorethamine
FDA approved
Find a Location
Closest Location:Investigator Site· Little Rock, AR
Who is running the clinical trial?
Helsinn Therapeutics (U.S.), IncLead Sponsor
11 Previous Clinical Trials
2,341 Total Patients Enrolled
Bill BaileyStudy DirectorHelsinn Therapeutics (U.S.), Inc