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.
Brief Title
Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Mycosis Fungoides
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
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
PROVe
CTCL
Mechlorethamine
Cutaneous T-cell lymphoma
Mycosis fungoides cutaneous T-cell lymphoma
Valchlor
Dermatology
MF-CTCL
Mycosis Fungoides
Oncology
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02296164
Org Class
Industry
Org Full Name
Helsinn Therapeutics (U.S.), Inc
Org Study Id
AC-079A501
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A PROspective, Observational, US-based Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma and Treated With Valchlor®
Primary Outcomes
Outcome Description
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.
Outcome Measure
Treatment Responders Using Body Surface Area (BSA) at 12 Months
Outcome Time Frame
12 Months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Primary Care Clinic
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741
Categories Mesh Debug
Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
MYCOSIS FUNGOIDES
LYMPHOMA, T-CELL, CUTANEOUS
NEOPLASMS
LYMPHOMA, T-CELL
LYMPHOMA, NON-HODGKIN
LYMPHOMA
NEOPLASMS BY HISTOLOGIC TYPE
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
HEMIC AND LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
AMINES
ORGANIC CHEMICALS