Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma (PROVe)
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| ClinicalTrials.gov Identifier: NCT02296164 |
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Recruitment Status :
Completed
First Posted : November 20, 2014
Results First Posted : December 5, 2019
Last Update Posted : March 4, 2020
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Sponsor:
Helsinn Therapeutics (U.S.), Inc
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Mycosis Fungoides | Drug: Valchlor |
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 Type : | Observational [Patient Registry] |
| Actual Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 2 Years |
| 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® |
| Actual Study Start Date : | November 12, 2014 |
| Actual Primary Completion Date : | October 17, 2018 |
| Actual Study Completion Date : | October 17, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Mycosis fungoides
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Drug: Valchlor
Valchlor gel 0.016%
Other Name: Mechlorethamine gel |
Primary Outcome Measures :
- Treatment Responders Using Body Surface Area (BSA) at 12 Months [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Primary Care Clinic
Criteria
Inclusion Criteria:
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296164
Locations
| United States, Arkansas | |
| Investigator Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Investigator Site | |
| Duarte, California, United States, 91010 | |
| Investigator Site | |
| La Mesa, California, United States, 91941 | |
| Investigator Site | |
| San Francisco, California, United States, 94115 | |
| Investigator Site | |
| Santa Ana, California, United States, 92701 | |
| United States, Colorado | |
| Investigator Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Investigator Site | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Investigator Site | |
| Coral Gables, Florida, United States, 33134 | |
| Investigator Site | |
| Hollywood, Florida, United States, 33021 | |
| Investigator Site | |
| Naples, Florida, United States, 34102 | |
| Investigator Site | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Investigator Site | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Illinois | |
| Investigator Site | |
| Chicago, Illinois, United States, 60611 | |
| Investigator Site | |
| Chicago, Illinois, United States, 60612 | |
| Investigator Site | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Investigator Site | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Investigator Site | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Investigator Site | |
| Ann Arbor, Michigan, United States, 48103 | |
| United States, Mississippi | |
| Investigator Site | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Investigator Site | |
| Saint Louis, Missouri, United States, 63104 | |
| Investigator Site | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Investigator Site | |
| Henderson, Nevada, United States, 89074 | |
| United States, New Jersey | |
| Investigator Site | |
| East Windsor, New Jersey, United States, 08520 | |
| United States, New York | |
| Investigator Site | |
| Bronx, New York, United States, 10467 | |
| Investigator Site | |
| Brooklyn, New York, United States, 11203 | |
| Investigator Site | |
| Fairport, New York, United States, 14450 | |
| Investigator Site | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Investigator Site | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Investigator Site | |
| Exton, Pennsylvania, United States, 19341 | |
| Investigator Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Investigator Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Investigator Site | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Investigator Site | |
| Charleston, South Carolina, United States, 29414 | |
| United States, Texas | |
| Investigator Site | |
| Dallas, Texas, United States, 75231 | |
| Investigator Site | |
| Dallas, Texas, United States, 75390 | |
| United States, Virginia | |
| Investigator Site | |
| Fairfax, Virginia, United States, 22031 | |
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Investigators
| Study Director: | Bill Bailey | Helsinn Therapeutics (U.S.), Inc |
Study Documents (Full-Text)
Documents provided by Helsinn Therapeutics (U.S.), Inc:
Documents provided by Helsinn Therapeutics (U.S.), Inc:
Study Protocol [PDF] December 13, 2016
Statistical Analysis Plan [PDF] November 22, 2019
Additional Information:
| Responsible Party: | Helsinn Therapeutics (U.S.), Inc |
| ClinicalTrials.gov Identifier: | NCT02296164 |
| Other Study ID Numbers: |
AC-079A501 |
| First Posted: | November 20, 2014 Key Record Dates |
| Results First Posted: | December 5, 2019 |
| Last Update Posted: | March 4, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | observational study |
Keywords provided by Helsinn Therapeutics (U.S.), Inc:
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PROVe CTCL Mechlorethamine Cutaneous T-cell lymphoma Mycosis fungoides cutaneous T-cell lymphoma |
Valchlor Dermatology MF-CTCL Mycosis Fungoides Oncology |
Additional relevant MeSH terms:
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Mycoses Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Mycosis Fungoides Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Bacterial Infections and Mycoses Infections Mechlorethamine Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Antineoplastic Agents |