Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Dermatitis

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycoses

Mycosis Fungoides

Dermatitis, Contact

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Skin Diseases

Lymphoma, Non-Hodgkin

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Skin Diseases, Eczematous

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Granulomatous Slack Skin Disease

Anti-Inflammatory Agents

All Drugs and Chemicals

Antineoplastic Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Mechlorethamine

Nitrogen Mustard Compounds

Glucocorticoids

Hormones

Hormone Antagonists

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Alkylating Agents

Antineoplastic Agents, Alkylating

0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.

0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months.

Apply up to three times daily on select lesions.

Apply valchlor nightly on select lesions.

Valchlor 0.016 % Topical Gel

Brian Poligone, MD, PhD

This is a two-arm, open-label study that aims to compare the incidence and severity of the most common adverse reactions, particularly contact dermatitis, when Valchlor is used alone or in conjunction with triamcinolone ointment 0.1% in early stage MF subjects (Stage IA and IB) for a period of 4 months.

Mechlorethamine hydrochloride, or most commonly known as nitrogen nitrogen mustard, was approved by the FDA in 2013 for the treatment of IA and IB Mycosis Fungoides. The most common side effect of Valchlor is a skin rash, which is routinely ameliorated with the application of topical corticosteroids, such as topical Triamcinolone. The main purpose of this study is to determine the efficacy of Triamcinolone in reducing side effects cause by Valchlor and further understand the nature of this skin rash.

This is a split-face study, meaning that subjects will receive both therapies, but limit use to designated areas. Treatment lasts 4 months with follow ups at 5 and 12 months.

Mechlorethamine Induced Contact Dermatitis Avoidance Study

Valchlor Therapy in Conjunction With Triamcinolone 0.1% Ointment for the Treatment of Contact Dermatitis in Patients With Early Stage Cutaneous T-cell Lymphoma (Mechlorethamine Induced Dermatitis Avoidance Study)

Data will be embargoed until the study site has fully examined it. Expected embargo would be one year from study completion.

Study data that is de-identified will be maintained at the study site. As this field is rapidly changing, if a database is available for safe, public upload at the end of study embargo, it will be uploaded to a national database. Otherwise requests for use of the study data will be accepted at the study site and shared with investigators whose proposed use of data has been approved by an independent institutional review board. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.

Scoring Atopic Dermatitis (SCORAD) differences between lesions treated with Valchlor and Triamcinolone versus lesions treated with Valchlor only. SCORAD measures the extent and severity of dermatitis. The percentage of total body surface area (0-100) covered by a lesion is measured by an investigator, and this number corresponds to score "A." The intensity criteria are met by scoring erythema, edema/papulation, oozing/crusting, excoriation, xerosis, and thickness on a scale of 0-3 (0=none, 1=mild, 2=Moderate, 3=Severe). These values are summed to give a total score, "B." Subjective symptoms of pruritus and insomnia are then scored using visual analogue scales ranging from 0-10 (0=none, 10=worst imaginable), and the result of each is summed to give score "C". The final score is then calculated by the formula A/5 + 7B/2 + C. The lowest possible score is 0, and the highest possible score is 103. A higher score indicates a worse outcome.

A lower score would be a better outcome.

Efficacy of Valchlor therapy with Triamcinolone compared to Valchlor using a composite assessment of index lesion severity (CAILS). CAILS is an objective, quantitative, method to assess the extent of skin lesions. Skin lesions and erythema will be evaluated using CAILS. A Composite Assessment will be generated for each time point by a summation of the grades for each index lesion's erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement. The index lesion grade at baseline will be divided into the grade at each subsequent study visit to determine the subject's response to treatment. Any ratio of the grade obtained at the visit vs. the one obtained at baseline that is \>1.0 will indicate worsening of disease.

Incidence of moderate to severe contact dermatitis in patients treated concurrently with Triamcinolone 0.1% ointment versus those that are not. Dermatitis will be defined as a finding of cutaneous inflammatory reaction occurring as a result of treatment. This will be assessed by the SCORD (SCORing Dermatitis) tool and may be confirmed by biopsy of the specimen. Moderate to Severe Contact dermatitis is defined as \>25 by SCORD.

The presence of allergic versus irritant dermatitis was characterized through skin biopsies sent for pathological review and patch testing. Subjects presenting to the clinic with dermatitis underwent patch testing to determine the presence of allergic vs. Irritant contact dermatitis, and at each case a biopsy sample was taken of the affected area to confirm the diagnosis. Patch testing was assessed by the investigator according to the International Contact Dermatitis Research Group scale, using the following for possible outcomes : ?+ indicates a doubtful reaction, 1+ indicates a weak reaction, 2+ represents a strong reaction, 3+ indicates an extreme reaction, and IR indicates an Irritant reaction. A higher score would indicate a worse outcome. 1-3+ reaction at the 96hr reading was considered positive for allergic contact dermatitis.

Rochester General Hospital

Rochester Skin Lymphoma Medical Group, PLLC

0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.

Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.

Valchlor 0.016% Topical Gel

0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months.

Triamcinolone: Apply up to three times daily on select lesions.

Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.

Valchlor Plus Triamcinolone

Group consisting of all trial participants that completed screening and randomization.

In this split-person study, lesions from one half of each participant's body are assigned to one of two treatment groups: One half of the body is assigned to treatment of affected lesions with Valchlor only, while the other half of the body is assigned to treatment of affected lesions with both Valchlor and Triamcinolone.

For the Valchlor only group, Valchlor is applied once nightly to the target lesions.

For the Valchlor + Triamcinolone group, 0.016% w/w topical mechlorethamine gel is applied once nightly to target lesions, and Triamcinolone acetonide 0.1% ointment is applied up to three time per day to target lesions over a minimum of 8 cm2

For both groups, the treatment period spanned four months.

All Participants

21-30

31-40

41-50

51-60

61-70

71-80

81-90

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Clinical Research Coordinator

Each patient had both treatments (self-controlled)

Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring

Group of all analyzed study participants. Both irritant and allergic contact dermatitis was observed

All analyzed trial participants Were included in assessment of dermatitis. 12 incidents of dermatitis were observed across the study, and at each incident a biopsy of the affected area was sent for histopathological review. 10 of 12 patients presented with allergic contact dermatitis, while 2 out of 10 12 patients presented with irritant contact dermatitis according to pathology results.

Nature of Contact Dermatitis (Allergic Versus Irritant)

Severity of Dermatitis

Average CAILS score at Baseline

Average CAILS score at Month 4

Efficacy of Valchlor vs Valchlor Plus Triamcinolone

Overall Study

Syndrome

Sezary Syndrome

Antibodies

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Mogamulizumab

Patients receive mogamulizumab IV over 60 minutes on days 1, 8, 15, 22, of cycle 1 and days 1 and 15 of subsequent cycles. Beginning in cycle 2, patients also undergo ECP over 3 hours on days 8, 9, 22,and 23. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving CR)/PR after 6 cycles receive up to 6 additional cycles of treatment in the absence of disease progression or unacceptable toxicity.

Extracorporeal Photopheresis

Quality-of-Life Assessment

Questionnaire Administration

Christiane R. Querfeld

Christiane R Querfeld

This phase II trial studies the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma. CTCL is a rare type of cancer that begins in the white blood cells called T cells. Erythrodermic is a widespread red rash that may cover most of the body. ECP is a medical treatment that removes blood with a machine, isolates white blood cells and exposes them to ultra violet light, then returns the cells to the body. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving mogamulizumab with ECP may work together to kill the tumor cells directly (with mogamulizumab) and boost immune response to cancer (with ECP).

PRIMARY OBJECTIVE:

I. To assess tolerability and overall response rate (ORR) of the (ECP)/mogamulizumab regimen in CTCL patients previously untreated with mogamulizumab.

SECONDARY OBJECTIVES:

I. To estimate complete response (CR) rate, time to response, duration of response, progression free survival, and overall survival in CTCL patients treated with the ECP/mogamulizumab combination.

II. To summarize the toxicities in CTCL patients treated with the ECP/mogamulizumab combination.

EXPLORATORY OBJECTIVES:

I. To assess quality of life (QoL) parameters before, during, and after the regimen.

II. To evaluate the anti-tumor and immunomodulatory effects of mogamulizumab in the CTCL microenvironment in skin and blood samples of erythrodermic CTCL patients.

III. To evaluate the immunomodulatory effects of ECP.

OUTLINE:

Patients receive mogamulizumab intravenously (IV) over 60 minutes on days 1, 8, 15, 22, of cycle 1 and days 1 and 15 of subsequent cycles. Beginning in cycle 2, patients also undergo ECP over 3 hours on days 8, 9, 22,and 23. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR)/partial response (PR) after 6 cycles receive up to 6 additional cycles of treatment in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then for up to 12 months.

Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma

A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL

ORR will be calculated as the proportion of evaluable patients that have confirmed complete response (CR) or partial response (PR), as defined according to global response assessment. Exact 95% confidence intervals will be calculated for these estimates.

Toxicity and adverse events will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 scale. Observed toxicities will be summarized by type, severity, date of onset, and attribution.

Defined as the proportion of response-evaluable patients that have a documented CR.

Will be estimated using the product-limit method of Kaplan and Meier.

National Cancer Institute (NCI)

City of Hope Medical Center

Recurrence

Disease Attributes

Channel Blockers

Bone Density Conservation Agents

Antibodies, Monoclonal

Lenalidomide

Brentuximab Vedotin

Piperidine

Antineoplastic Agents, Immunological

Immunoconjugates

Angiogenesis Inhibitors

Growth Inhibitors

Immunotoxins

Calcium

Calcium Channel Blockers

Calcium, Dietary

Patients receive brentuximab vedotin IV over 30 minutes on day 1 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Jasmine Zain, MD

This phase I trial studies the side effects and best dose of lenalidomide when given together with brentuximab vedotin in treating patients with T-cell lymphomas that have come back or do not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin and lenalidomide may work better in treating patients with T-cell lymphomas.

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD)/Recommended Phase 2 dose (RP2D) of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory cutaneous T-cell lymphoma (CTCL).

II. Assess safety and tolerability of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory CTCL.

SECONDARY OBJECTIVES:

I. Estimate the rate of objective global response that lasts at least 4 months (ORR4) , complete response (CR) rate, progression-free survival (PFS) of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory CTCL.

II. Estimate the rate and duration of clinically meaningful reduction in pruritus (CMRP).

III. Correlate response to baseline CD30 levels in tissue samples.

TERTIARY OBJECTIVES:

I. Estimate the response endpoints incorporating Lugano response criteria for patients with PET+ disease.

II. Explore temporal gene expression profile in skin/ blood samples that may predict response to combination therapy.

OUTLINE: This is a dose-escalation study of lenalidomide.

Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then up to 12 months.

Brentuximab Vedotin and Lenalidomide in Treating Patients With Relapsed or Refractory T-Cell Lymphomas

A Phase 1 Trial of Brentuximab Vedotin Plus Lenalidomide in Patients With Relapsed/ Refractory Cutaneous T-Cell Lymphomas

Will be estimated by the proportion of patients achieving a CR/PR that lasts at least 4 months, along with the 95% exact binomial confidence interval.

Complete response rate will be estimated by the proportion of evaluable patients achieving CR, along with the 95% exact binomial confidence interval.

PFS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error.

Pruritus visual analogue scale (VAS) is a horizontal 100mm long line on which the patients make a vertical mark to indicate their subjective assessment of pruritus intensity; the patients are informed that the scale represents no pruritus (0 points) to severe pruritus (100 points). Changes from baseline over time in pruritus VAS score will be assessed using descriptive statistics.

Baseline CD30 levels in tissue samples by immunochemistry will be compared between responders and non-responders by Fisher's exact test. Log rank test will be used to explore the association between baseline CD30 levels in tissue samples with PFS.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mechlorethamine Induced Contact Dermatitis Avoidance Study	NCT03380026	Cutaneous T-cel... Cutaneous T-cel... Mycosis Fungoid... Folliculotropic... Granulomatous S... Syringotropic M... Mycosis Fungoid... Transformed Myc...	Triamcinolone Valchlor 0.016 ...	18 Years -	Rochester Skin Lymphoma Medical Group, PLLC
Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma	NCT04930653	Folliculotropic... Primary Cutaneo... Sezary Syndrome Stage IB Mycosi... Stage II Mycosi... Stage IIA Mycos... Stage IIB Mycos... Transformed Myc...	Extracorporeal ... Mogamulizumab Quality-of-Life... Questionnaire A...	18 Years -	City of Hope Medical Center
Brentuximab Vedotin and Lenalidomide in Treating Patients With Relapsed or Refractory T-Cell Lymphomas	NCT03373305	CD30-Positive N... Folliculotropic... Recurrent Mycos... Recurrent Prima... Refractory Myco... Refractory Prim... Sezary Syndrome	Brentuximab Ved... Lenalidomide Laboratory Biom...	18 Years -	City of Hope Medical Center
Brentuximab Vedotin and Lenalidomide in Treating Patients With Relapsed or Refractory T-Cell Lymphomas	NCT03373305	CD30-Positive N... Folliculotropic... Recurrent Mycos... Recurrent Prima... Refractory Myco... Refractory Prim... Sezary Syndrome	Brentuximab Ved... Lenalidomide Laboratory Biom...	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for folliculotropic mycosis fungoides