Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (PG - NM (MCH) 0.02%) | Active Comparator | PG - mechlorethamine-MCH (nitrogen mustard) 0.02% gel To evaluate the tolerability and safety of topical mechlorethamine-MCH (nitrogen mustard) 0.02% ointment formulations in patients with stage I or IIA MF |
|
| 2 (AP - MCH(NM) 0.02%) | Active Comparator | AP - mechlorethamine-MCH (nitrogen mustard) 0.02% compounded in Aquaphor To evaluate the tolerability and safety of mechlorethamine-MCH (nitrogen mustard)0.02% ointment formulations in patients with stage I or IIA MF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessment made at Day 1 and every subsequent visit during treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stuart Lessin, M.D. | Fox Chase Cancer Center | Study Director |
| 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 |
|---|---|---|---|
| 12588222 | Background | Kim YH, Martinez G, Varghese A, Hoppe RT. Topical nitrogen mustard in the management of mycosis fungoides: update of the Stanford experience. Arch Dermatol. 2003 Feb;139(2):165-73. doi: 10.1001/archderm.139.2.165. | |
| 14686971 | Background | Kim YH. Management with topical nitrogen mustard in mycosis fungoides. Dermatol Ther. 2003;16(4):288-98. doi: 10.1111/j.1396-0296.2003.01640.x. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel | Study formulation of Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel |
| FG001 | AP- Mechlorethamine 0.02% Compounded in Aquaphor |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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.
| Baseline to end of therapy |
| Chicago |
| Illinois |
| 61611 |
| United States |
| NYU Medical Center Dept. of Dermatology | New York | New York | 10016 | United States |
| Columbia University, Dept. of Dermatology | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Oklahoma University | Tulsa | Oklahoma | 74104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | 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 |
| 8915308 | Background | Kim YH, Jensen RA, Watanabe GL, Varghese A, Hoppe RT. Clinical stage IA (limited patch and plaque) mycosis fungoides. A long-term outcome analysis. Arch Dermatol. 1996 Nov;132(11):1309-13. |
| 37802679 | Derived | Geskin LJ, Angello JT, Bagot M, Guenova E, Nikbakht N, Querfeld C, Scarisbrick JJ. Evaluating Response Trends of Chlormethine/Mechlorethamine Gel in Patients With Stage I-IIA Mycosis Fungoides: Analysis of Individual Patient Data From a Randomized Controlled Phase II Study to Facilitate Optimal Treatment Experiences. Clin Lymphoma Myeloma Leuk. 2024 Jan;24(1):40-47. doi: 10.1016/j.clml.2023.08.020. Epub 2023 Sep 7. |
| 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. |
| 34091453 | Derived | Querfeld C, Scarisbrick JJ, Assaf C, Guenova E, Bagot M, Ortiz-Romero PL, Quaglino P, Bonizzoni E, Hodak E. Post hoc Analysis of a Randomized, Controlled, Phase 2 Study to Assess Response Rates with Chlormethine/Mechlorethamine Gel in Patients with Stage IA-IIA Mycosis Fungoides. Dermatology. 2022;238(2):347-357. doi: 10.1159/000516138. Epub 2021 Jun 4. |
| 23069814 | Derived | 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. |
Compounded Mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel |
| BG001 | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02% |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | ITT | Posted | Number | percentage of participants | Assessment made at Day 1 and every subsequent visit during treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks | Not Posted | Assessment made at Day 1 and every subsequent visit during treatment | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | Percent of participants | Baseline to end of therapy |
|
|
adverse event data were collected over 12 months of the patient's participation
There were a total of 130 participants randomized to each treatment arm. However, 2 from the PG group and 3 from the AP group did not receive drug and are not included in the safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel | 0 | 128 | 108 | 128 | ||
| EG001 | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02% | 0 | 127 | 99 | 127 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| folliculitis | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Jeffrey Wilkins, MD | Yaupon Therapeutics | 4843247935 | 935 | hjwilkins@yaupontherapeutics.com |
| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D008466 | Mechlorethamine |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|