Mechlorethamine Induced Contact Dermatitis Avoidance Study

NCT ID: NCT03380026

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2020-12-13

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.

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.

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Valchlor 0.016 % Topical Gel

Intervention Type: DRUG

Apply valchlor nightly on select lesions.

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.

Group Type: ACTIVE_COMPARATOR

Triamcinolone

Intervention Type: DRUG

Apply up to three times daily on select lesions.

Valchlor 0.016 % Topical Gel

Intervention Type: DRUG

Apply valchlor nightly on select lesions.

Interventions

Triamcinolone

Apply up to three times daily on select lesions.

Intervention Type: DRUG

Valchlor 0.016 % Topical Gel

Apply valchlor nightly on select lesions.

Intervention Type: DRUG

Other Intervention Names

triamcinolone acetonide; Triamcinolone 0.1% ointment; topical nitrogen mustard; mechlorethamine hydrochloride; mechlorethamine gel

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rochester General Hospital

OTHER

Sponsor Role: collaborator

Rochester Skin Lymphoma Medical Group, PLLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Poligone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rochester Skin Lymphoma Medical Group, PLLC

Locations

Rochester Skin Lymphoma Medical Group, PLLC

Fairport, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23069814 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35122614 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202317lbl.pdf

Valchlor package insert

https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=12961

Triamcinolone acetonide information

Other Identifiers

RSLMG-17.10

Identifier Type: -

Identifier Source: org_study_id