This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).
The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Since then, multiple investigators have demonstrated the safety and efficacy of topically applied MCH in the treatment of mycosis fungoides. This study will evaluate the efficacy (non-inferiority), tolerability and safety of topical application of MCH proprietary gel versus a compounded ointment formulation in Aquaphor in patients with stage I or IIA MF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
260
All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment
Stanford University Medical Center
Stanford, California, United States
Northwestern University - Dept. of Dermatology
Chicago, Illinois, United States
NYU Medical Center Dept. of Dermatology
New York, New York, United States
Ratio of Response Rates Based on CAILS
The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment
Time frame: Assessment made at Day 1 and every subsequent visit during treatment
Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks
Time frame: Assessment made at Day 1 and every subsequent visit during treatment
Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)
Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart.
Time frame: Baseline to end of therapy
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Columbia University, Dept. of Dermatology
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Oklahoma University
Tulsa, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, United States
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States
...and 2 more locations