Mycosis Fungoides
Conditions
Keywords
PROVe, CTCL, Mechlorethamine, Cutaneous T-cell lymphoma, Mycosis fungoides cutaneous T-cell lymphoma, Valchlor, Dermatology, MF-CTCL, Mycosis Fungoides, Oncology
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
Interventions
DRUGValchlor
Valchlor gel 0.016%
Sponsors
Helsinn Therapeutics (U.S.), Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
The study registered 301 consecutive adult patients (Only registered/not enrolled:1; Enrolled: 300) diagnosed with MF-CTCL and being treated with Valchlor, regardless of other MF-CTCL therapies received before or at enrollment. All patients were enrolled from 46 participating centers/clinics in university-affiliated or community hospitals in the US
Pre-assignment details
All consecutive MF-CTCL patients being treated with Valchlor were invited to enroll in this study. Two patients were not eligible as they were not on Valchlor at time of study start
Participants by arm
| Arm | Count |
|---|---|
| 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: Valchlor gel 0.016% | 298 |
| Total | 298 |
Baseline characteristics
| Characteristic | MF-CTCL Patients Receiving Valchlor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 136 Participants |
| Age, Categorical Between 18 and 65 years | 162 Participants |
| diagnosed with MF-CTCL and being treated with Valchlor. | 298 Participants |
| Race/Ethnicity, Customized African American | 45 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 11 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 29 Participants |
| Race/Ethnicity, Customized Native Hawaiian/other Pacific Islander | 6 Participants |
| Race/Ethnicity, Customized Not Disclosed | 203 Participants |
| Race/Ethnicity, Customized Unknown or ≥2 races/ethnicities | 2 Participants |
| Region of Enrollment United States | 298 Participants |
| Sex: Female, Male Female | 119 Participants |
| Sex: Female, Male Male | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 298 |
| other Total, other adverse events | 104 / 298 |
| serious Total, serious adverse events | 23 / 298 |
Outcome results
Primary
Treatment Responders Using Body Surface Area (BSA) at 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.
Time frame: 12 Months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MF-CTCL Patients Receiving Valchlor | Treatment Responders Using Body Surface Area (BSA) at 12 Months | 44 Participants |