Mechlorethamine Induced Contact Dermatitis Avoidance Study

NCT03380026 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RSLMG-17.10
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

CTCL; topical mechlorethamine; Valchlor; contact dermatitis; triamcinolone; MF; Cutaneous T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring

  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.

  4 months

Secondary Outcomes (1)

• Nature of Contact Dermatitis (Allergic Versus Irritant)

  4 months

Other Outcomes (2)

• Severity of Dermatitis

  4 months

• Efficacy of Valchlor vs Valchlor Plus Triamcinolone

  4 months

Study Arms (2)

Valchlor 0.016% Topical Gel

EXPERIMENTAL

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

Valchlor plus Triamcinolone

ACTIVE COMPARATOR

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; Drug: Valchlor 0.016 % Topical Gel

Interventions

Triamcinolone DRUG

Apply up to three times daily on select lesions.

Also known as: triamcinolone acetonide, Triamcinolone 0.1% ointment

Valchlor plus Triamcinolone

Valchlor 0.016 % Topical Gel DRUG

Apply valchlor nightly on select lesions.

Also known as: topical nitrogen mustard, mechlorethamine hydrochloride, mechlorethamine gel

Valchlor 0.016% Topical Gel; Valchlor plus Triamcinolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rochester Skin Lymphoma Medical Group, PLLC: lead
• Rochester General Hospital: collaborator

Study Sites (1)

Rochester Skin Lymphoma Medical Group, PLLC

Fairport, New York, 14450, United States

Location

Related Publications (2)

• Lessin SR, Duvic M, Guitart J, Pandya AG, Strober BE, Olsen EA, Hull CM, Knobler EH, Rook AH, Kim EJ, Naylor MF, Adelson DM, Kimball AB, Wood GS, Sundram U, Wu H, Kim YH. Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013 Jan;149(1):25-32. doi: 10.1001/2013.jamadermatol.541.

  PMID: 23069814 BACKGROUND

• Alexander-Savino CV, Chung CG, Gilmore ES, Carroll SM, Poligone B. Randomized Mechlorethamine/Chlormethine Induced Dermatitis Assessment Study (MIDAS) Establishes Benefit of Topical Triamcinolone 0.1% Ointment Cotreatment in Mycosis Fungoides. Dermatol Ther (Heidelb). 2022 Mar;12(3):643-654. doi: 10.1007/s13555-022-00681-6. Epub 2022 Feb 5.

  PMID: 35122614 DERIVED

Related Links

• Valchlor package insert
• Triamcinolone acetonide information

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Dermatitis, Contact

Interventions

Triamcinolone; Triamcinolone Acetonide; Ointments; Amines; Gels; Mechlorethamine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations; Organic Chemicals; Colloids; Complex Mixtures; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Rochester Skin Lymphoma Medical Group

scarroll@roclymphoma.com

(585)364-1188

Study Officials

• Brian Poligone, MD, PhD

  Rochester Skin Lymphoma Medical Group, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label, split-face study

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 20, 2017
• Study Start: December 13, 2017
• Primary Completion: August 3, 2020
• Study Completion: December 13, 2020
• Last Updated: November 24, 2021
• Results First Posted: November 24, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)