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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-12

Study Completion Date

2018-10-17

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Mycosis Fungoides

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MF-CTCL Patients receiving 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.

Valchlor

Intervention Type DRUG

Valchlor gel 0.016%

Interventions

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Valchlor

Valchlor gel 0.016%

Intervention Type DRUG

Other Intervention Names

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Mechlorethamine gel

Eligibility Criteria

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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.