CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 260 enrolled
Drug / intervention
mechlorethamine-MCH (nitrogen mustard)drug
Likely dose
Mechlorethamine (nitrogen mustard) 0.02% ointment applied to all affected areas once daily for 12 monthsAI-extracted
Key inclusion· 6
  • ✓Confirmed mycosis fungoides by skin biopsy
  • ✓Stage I or IIA disease
  • ✓Prior treatment with topical therapies (PUVA, UVB, topical steroids, or BCNU), but not NM within past 2 years
  • ✓No topical therapy within 4 weeks prior to study start
Key exclusion· 8
  • ✕Newly diagnosed MF with no prior therapy
  • ✕Prior treatment with topical NM within past 2 years or topical BCNU
  • ✕Topical or systemic MF therapy within 4 weeks of entry
  • ✕Stage IIB-IV MF

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00168064
NCT00168064Phase 2Completed
CompareCT.gov

A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)

Yaupon Therapeutics·interventional·Posted Sep 14, 2005·Updated Oct 31, 2012

In Brief

A Phase 2 clinical trial evaluating mechlorethamine-MCH (nitrogen mustard) for Mycosis Fungoides. Completed, enrolled 260 participants across 12 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMycosis Fungoides
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartMay 1, 2006
Primary CompletionAug 1, 2010
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

mechlorethamine-MCH (nitrogen mustard)drug

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