N/A
N=298
Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
Mycosis Fungoides
Bottom Line
View on ClinicalTrials.gov: NCT02296164 ↗Enrolled (actual)
298
Serious AEs
7.7%
Results posted
Dec 2019
Primary outcome: Primary: Treatment Responders Using Body Surface Area (BSA) at 12 Months — 44 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Valchlor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Helsinn Therapeutics (U.S.), Inc
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Responders Using Body Surface Area (BSA) at 12 Months |
44 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02296164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.