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Mechlorethamine Induced Contact Dermatitis Avoidance Study (MIDAS)

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ClinicalTrials.gov Identifier: NCT03380026
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Rochester General Hospital
Information provided by (Responsible Party):
Rochester Skin Lymphoma Medical Group, PLLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cutaneous T-cell Lymphoma Cutaneous T-cell Lymphoma Stage I Mycosis Fungoides Folliculotropic Mycosis Fungoides Granulomatous Slack Skin Syringotropic Mycosis Fungoides Mycosis Fungoides Variant Transformed Mycosis Fungoides Drug: Triamcinolone Drug: Valchlor 0.016 % Topical Gel Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, split-face study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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)
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : December 13, 2019
Estimated Study Completion Date : December 13, 2020


Arm Intervention/treatment
Experimental: Valchlor 0.016% Topical Gel
0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.
Drug: Valchlor 0.016 % Topical Gel
Apply valchlor nightly on select lesions.
Other Names:
  • topical nitrogen mustard
  • mechlorethamine hydrochloride
  • mechlorethamine gel

Active Comparator: Valchlor plus Triamcinolone
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.
Drug: Triamcinolone
Apply up to three times daily on select lesions.
Other Names:
  • triamcinolone acetonide
  • Triamcinolone 0.1% ointment

Drug: Valchlor 0.016 % Topical Gel
Apply valchlor nightly on select lesions.
Other Names:
  • topical nitrogen mustard
  • mechlorethamine hydrochloride
  • mechlorethamine gel




Primary Outcome Measures :
  1. Incidence of Contact Dermatitis [ Time Frame: 4 months ]
    Incidence (%) of dermatitis in lesions 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 as a value of present or not present, and may be confirmed by biopsy of the specimen.


Secondary Outcome Measures :
  1. Nature of Contact Dermatitis (Allergic versus Irritant) [ Time Frame: 4 months ]
    The presence of allergic versus irritant dermatitis will be characterized through skin biopsies sent for pathological review, patch testing, and measuring the genetic variability of the T-cell clones through sequencing of the CD3 region of all T-cell clones found in skin biopsies collected at timepoints when contact dermatitis develop versus those collected at baseline.


Other Outcome Measures:
  1. Severity of Dermatitis [ Time Frame: 4 months ]
    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 (Score ranges: Mild: below 25, Moderate: between 25 and 50, and Severe: above 50). A lower score would be a better outcome.

  2. Pruritus and sleep disturbance [ Time Frame: 4 months ]
    To determine if there is any difference in pruritus and sleep disturbance caused by itch among lesions treated with Valchlor or Valchlor and Triamcinolone, measured as an average of a composite score of pruritus in each individual lesion for each treatment arm. Scores will range from 0 (least itch and sleep disturbance) to 10 (worst imaginable itch and sleep disturbance).

  3. Rate of skin hyperpigmentation [ Time Frame: 4 months ]
    To determine rate (%) and severity of hyperpigmentation in both treatment groups.

  4. Rate of ulceration [ Time Frame: 4 months ]
    To determine rate (%) and severity of ulceration in both treatment groups.

  5. Rate of skin blistering [ Time Frame: 4 months ]
    To determine rate (%) and severity of skin blistering in both treatment groups.

  6. Efficacy of Valchlor vs Valchlor plus Triamcinolone [ Time Frame: 4 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be eligible to receive Valchlor therapy.
  • Be at least of 18 years of age and ability to give informed consent
  • Have stage IA or IB CTCL
  • Subjects with histologic variants of Mycosis Fungoides such as folliculotropic, granulomatous slack skin, syringotropic MF, or large cell transformation ARE eligible.
  • A skin biopsy within the last 60 days before start of treatment. In cases with equivocal histological features, the diagnosis may be confirmed with clinicopathologic and/or genetic testing consistent with the National Comprehensive Cancer Network guidelines for Mycosis Fungoides. If sufficient tissue is not available to perform genetic testing, a new biopsy will be performed even if the subject has had a biopsy within 60 days of start of treatment.
  • Females of child bearing potential must agree to use two highly effective methods of contraception (strongly recommended that one of the two forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or have a vasectomized partner) or use an intrauterine device until 30 days after the last day of drug administration. Perimenopausal women must be amenorrhoeic for at least 12 months to be considered of nonchildbearing potential.
  • Males with female partners of child bearing potential must agree to sexual abstinence or use two reliable forms of effective contraception simultaneously (strongly recommended that one of the two forms should be non-hormonal as described above) during the entire treatment period and 30 days after the last dose.
  • Must be able to comply with the study instructions, apply the study medication as directed, and attend all visits.
  • Willingness to avoid sun exposure and ultraviolet B light in areas to be treated.

Exclusion Criteria:

  • Have been treated with topical mechlorethamine within 6 months in lesions followed during this study.
  • Have received any topical therapy directed against MF within 2 weeks of start of treatment in areas intended to be treated in this study.
  • Have received any systemic therapy (oral or injectables) within 3 weeks of start of treatment.
  • Not have any intercurrent illness or infection that would interfere with study participation
  • Known hypersensitivity to mechlorethamine or triamcinolone.
  • Breastfeeding, pregnancy, or intention to become pregnant.

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): NCT03380026


Contacts
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Contact: Shelley Secor-Socha, MS, CCRA 585-364-1188 ssecorsocha@roclymphoma.com
Contact: Brian Poligone, MD, PhD 585-364-1191 bpoligone@roclymphoma.com

Locations
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United States, New York
Rochester Skin Lymphoma Medical Group, PLLC Recruiting
Fairport, New York, United States, 14450
Contact: Brian Poligone, MD, PhD    585-364-1191    bpoligone@roclymphoma.com   
Principal Investigator: Brian Poligone, MD, PhD         
Sub-Investigator: Elaine Gilmore, MD, PhD         
Sponsors and Collaborators
Rochester Skin Lymphoma Medical Group, PLLC
Rochester General Hospital
Investigators
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Principal Investigator: Brian Poligone, MD, PhD Rochester Skin Lymphoma Medical Group, PLLC

Additional Information:
Publications:
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Responsible Party: Rochester Skin Lymphoma Medical Group, PLLC
ClinicalTrials.gov Identifier: NCT03380026     History of Changes
Other Study ID Numbers: RSLMG-17.10
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Clinical Study Report (CSR)
Time Frame: Expected embargo would be one year from study completion. De-identified data will be maintained at the study site for 2 years after the study ends. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.
Access Criteria: Data will be shared with investigators whose proposed use of data has been approved by an independent institutional review board.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rochester Skin Lymphoma Medical Group, PLLC:
CTCL
topical mechlorethamine
Valchlor
contact dermatitis
triamcinolone
MF
Cutaneous T-cell Lymphoma

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Lymphoma
Dermatitis
Lymphoma, T-Cell
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Dermatitis, Contact
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Skin Diseases
Lymphoma, Non-Hodgkin
Skin Diseases, Eczematous
Mechlorethamine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action