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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valchlor | Drug | Valchlor gel 0.016% |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
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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:
Signed patient informed consent.
Exclusion Criteria:
• None
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Bill Bailey | Helsinn Therapeutics (U.S.), Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Little Rock | Arkansas | 72205 | United States | ||
| Investigator Site |
observational study
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 QOL, there were no specific or mandated clinical assessments performed, and patients did not receive experimental intervention or treatment as a consequence of their participation in this study. Continuation in the study was not contingent on continuation of Valchlor. Valchlor: Valchlor gel 0.016% |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2016 | Oct 10, 2019 |
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| Duarte |
| California |
| 91010 |
| United States |
| Investigator Site | La Mesa | California | 91941 | United States |
| Investigator Site | San Francisco | California | 94115 | United States |
| Investigator Site | Santa Ana | California | 92701 | United States |
| Investigator Site | Aurora | Colorado | 80045 | United States |
| Investigator Site | New Haven | Connecticut | 06520 | United States |
| Investigator Site | Coral Gables | Florida | 33134 | United States |
| Investigator Site | Hollywood | Florida | 33021 | United States |
| Investigator Site | Naples | Florida | 34102 | United States |
| Investigator Site | Tampa | Florida | 33612 | United States |
| Investigator Site | Atlanta | Georgia | 30328 | United States |
| Investigator Site | Chicago | Illinois | 60611 | United States |
| Investigator Site | Chicago | Illinois | 60612 | United States |
| Investigator Site | Chicago | Illinois | 60637 | United States |
| Investigator Site | New Orleans | Louisiana | 70112 | United States |
| Investigator Site | Boston | Massachusetts | 02215 | United States |
| Investigator Site | Ann Arbor | Michigan | 48103 | United States |
| Investigator Site | Jackson | Mississippi | 39216 | United States |
| Investigator Site | St Louis | Missouri | 63104 | United States |
| Investigator Site | St Louis | Missouri | 63110 | United States |
| Investigator Site | Henderson | Nevada | 89074 | United States |
| Investigator Site | East Windsor | New Jersey | 08520 | United States |
| Investigator Site | Brooklyn | New York | 11203 | United States |
| Investigator Site | Fairport | New York | 14450 | United States |
| Investigator Site | New York | New York | 10032 | United States |
| Investigator Site | The Bronx | New York | 10467 | United States |
| Investigator Site | Cleveland | Ohio | 44106 | United States |
| Investigator Site | Exton | Pennsylvania | 19341 | United States |
| Investigator Site | Philadelphia | Pennsylvania | 19104 | United States |
| Investigator Site | Philadelphia | Pennsylvania | 19107 | United States |
| Investigator Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Investigator Site | Charleston | South Carolina | 29414 | United States |
| Investigator Site | Dallas | Texas | 75231 | United States |
| Investigator Site | Dallas | Texas | 75390 | United States |
| Investigator Site | Fairfax | Virginia | 22031 | United States |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Adult Males and Females | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||||
| diagnosed with MF-CTCL and being treated with Valchlor. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
The definition of an on-study event is one that occurs on the day of enrollment or later, but before the date of study discontinuation or completion ( 2 years).
The frequency and percentage of patients experiencing any on-study Adverse Events (AEs), Serious Adverse Events (SAEs), or death.
Additional detail for Adverse Events (AEs) of special interest (e.g., dermatitis).
Serious Adverse Events (SAEs) both including and excluding events that were not concurrent with Valchlor exposure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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% | 0 | 298 | 23 | 298 | 104 | 298 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Device related sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Endocarditis bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anaplastic large cell lymphoma T- and null-cell types | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Skin cancer with HLT skin neoplasm malignant and unspecified (exc. Melanoma) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Packed red blood cell transfusion | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Jugular vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Venous thrombosis limb | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bill Bailey | Helsinn Therapeutics (U.S.), Inc. | +1 732 603 2848 | bill.bailey@helsinn.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2019 | Dec 4, 2019 | SAP_002.pdf |
| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000588 | Amines |
| ID | Term |
|---|---|
| D009930 | Organic Chemicals |
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| Hispanic or Latino |
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| Asian |
|
| Native Hawaiian/other Pacific Islander |
|
| Unknown or ≥2 races/ethnicities |
|
| Not Disclosed |
|