Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma

Completed

• Conditions: Mycosis Fungoides
• Interventions: Drug: Valchlor

• Registration Number: NCT02296164
• Lead Sponsor: Helsinn Therapeutics (U.S.), Inc

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

Study Timeline

• Study First Submitted: 2014-11-07
• Study Start: 2014-11-12
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-20
• Primary Completion: 2018-10-17
• Study Completion: 2018-10-17
• Results First Submitted: 2019-10-11
• Results First Submitted QC: 2019-11-18
• Results First Posted: 2019-12-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MF-CTCL Patients receiving Valchlor	Valchlor	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.

Primary Outcome Measures

Name	Time	Method
Treatment Responders Using Body Surface Area (BSA) at 12 Months	12 Months	The primary efficacy endpoint was the proportion of patients who are responders to treatment at the 12-month timepoint using a ≥50% reduction from baseline in BSA as the definition of a responder in the group of patients who used mechlorethamine plus corticosteroids and possibly another treatment.

Trial Locations

Locations (1)

Investigator Site; 🇺🇸 Fairfax, Virginia, United States