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To evaluate the efficacy and safety of topical application of MCH 0.04% in a propylene glycol ointment (PG)in patients with stage I or IIA MF previously treated with MCH 0.02% in a PG or AP ointment who did not achieve a complete response.
This is a multi-center, open-label study of patients with previously treated stage I (IA and IB) or IIA MF who have not received a complete response after completing 12 months of treatment in clinical trial (2005NMMF-201-US)to either 0.02% MCH PG or 0.02% MCH in Aquaphor (AP) ointment formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Open label 0.04% Mechlorethamine gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.04% Mechlorethamine gel | Drug | Mechlorethamine 0.04% PG applied to affected skin areas (lesions) once daily for up to seven (7) months. The frequency of application may be adjusted for toxicity. After seven (7) months, they will be terminated from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of topical application of NM 0.04% in a propylene glycol ointment (PG) in patients with stage I or IIA MF | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in patients with stage I or IIA MF | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Lessin, M.D. | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| Northwestern University-Dept. of Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35536441 | Derived | Querfeld C, Scarisbrick JJ, Assaf C, Kim YH, Guitart J, Quaglino P, Hodak E. Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data. Am J Clin Dermatol. 2022 Jul;23(4):561-570. doi: 10.1007/s40257-022-00687-y. Epub 2022 May 10. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 28, 2013 | |
| Reset | Mar 4, 2013 | |
| Release | Jun 19, 2013 |
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|
| Chicago |
| Illinois |
| 61611 |
| United States |
| Columbia University, Dept of Dermatology | New York | New York | 10016 | United States |
| NYU Medical Center Dept. of Dermatology | New York | New York | 10016 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Oklahoma University | Tulsa | Oklahoma | 74104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| University of Texas, Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The University of Texas, M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Utah Clinical Trials, LLC | Salt Lake City | Utah | 84107 | United States |
| University of Wisconsin | Madison | Wisconsin | 53791 | United States |
| Reset | Jul 25, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 28, 2013 | Mar 4, 2013 | |||
| Jun 19, 2013 | Jul 25, 2013 |
| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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