Mycosis FungoidesPROVeNCT02296164
Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
An observational study of Mycosis Fungoides, run by Helsinn Therapeutics (U.S.), Inc at 36 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides
- What is being tested?
- Valchlor
- How many people
- 300 participants
- Where
- 36 sitesUnited States
- Study dates
- 12 Nov 2014to 17 Oct 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Investigator Site
Ann Arbor, Michigan, 48103
Investigator Site
Atlanta, Georgia, 30328
Investigator Site
Aurora, Colorado, 80045
Investigator Site
Boston, Massachusetts, 02215
Investigator Site
Brooklyn, New York, 11203
Investigator Site
Charleston, South Carolina, 29414
Investigator Site
Chicago, Illinois, 60611
Investigator Site
Chicago, Illinois, 60612
Investigator Site
Chicago, Illinois, 60637
Investigator Site
Cleveland, Ohio, 44106
Investigator Site
Coral Gables, Florida, 33134
Investigator Site
Dallas, Texas, 75231
Investigator Site
Dallas, Texas, 75390
Investigator Site
Duarte, California, 91010
Investigator Site
East Windsor, New Jersey, 08520
Investigator Site
Exton, Pennsylvania, 19341
Investigator Site
Fairfax, Virginia, 22031
Investigator Site
Fairport, New York, 14450
Investigator Site
Henderson, Nevada, 89074
Investigator Site
Hollywood, Florida, 33021
Investigator Site
Jackson, Mississippi, 39216
Investigator Site
La Mesa, California, 91941
Investigator Site
Little Rock, Arkansas, 72205
Investigator Site
Naples, Florida, 34102
Investigator Site
New Haven, Connecticut, 06520
Investigator Site
New Orleans, Louisiana, 70112
Investigator Site
New York, New York, 10032
Investigator Site
Philadelphia, Pennsylvania, 19104
Investigator Site
Philadelphia, Pennsylvania, 19107
Investigator Site
Pittsburgh, Pennsylvania, 15213
Investigator Site
San Francisco, California, 94115
Investigator Site
Santa Ana, California, 92701
Investigator Site
St Louis, Missouri, 63104
Investigator Site
St Louis, Missouri, 63110
Investigator Site
Tampa, Florida, 33612
Investigator Site
The Bronx, New York, 10467
About this study
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®
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.
Read the 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
- Conditions
- Mycosis Fungoides
- Being tested
- Valchlor
- Keywords
- PROVe, CTCL, Mechlorethamine, Cutaneous T-cell lymphoma, Mycosis fungoides cutaneous T-cell lymphoma, Valchlor, Dermatology, MF-CTCL, Mycosis Fungoides, Oncology
- Medical subject headings
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValchlorDrug
Also called Mechlorethamine gel
Valchlor gel 0.016%
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Valchlor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start12 Nov 2014
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Helsinn Therapeutics (U.S.), Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bill Bailey, Study director, Helsinn Therapeutics (U.S.), Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296164
- Sponsor's protocol ID
- AC-079A501
- Acronym
- PROVe
- Status last verified
- Feb 2020
- First submitted
- 7 Nov 2014
- Last updated
- 4 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: observational study
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®
- ClinicalTrials.gov ID
- NCT02296164
- Acronym / sponsor ID
- PROVe / AC-079A501
- Conditions
- Mycosis Fungoides
- Keywords
- PROVe, CTCL, Mechlorethamine, Cutaneous T-cell lymphoma, Mycosis fungoides cutaneous T-cell lymphoma, Valchlor, Dermatology, MF-CTCL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Helsinn Therapeutics (U.S.), IncIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 5 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MF-CTCL Patients receiving Valchlor | – | Drug: ValchlorPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (4 listed)
- 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:
- Signed patient informed consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValchlorAlso: Mechlorethamine gelValchlor gel 0.016% | Drug | MF-CTCL Patients receiving Valchlor |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. observational study
Related trials for Mycosis Fungoides
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Active, not recruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill Bailey study director
Helsinn Therapeutics (U.S.), Inc
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycosis Fungoides, run by Helsinn Therapeutics (U.S.), Inc at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Responders Using Body Surface Area (BSA) at 12 Months (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.