A Phase 2 interventional study of mechlorethamine-MCH (nitrogen mustard) in Mycosis Fungoides, sponsored by Yaupon Therapeutics. Completed at 12 sites in United States. Per ClinicalTrials.gov, last updated 2012-10-31.
Sponsored by Yaupon Therapeutics · Phase 2, Interventional, and Treatment
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.
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's enrollment of 260 is above the median of 46 across 358 interventional studies indexed under Mycoses.
Browse Mycoses studies →Yaupon Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Drug: mechlorethamine-MCH (nitrogen mustard)
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
Drug: mechlorethamine-MCH (nitrogen mustard)
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
Also known as: mechlorethamine, nitrogen mustard
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
| Milestone | PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel | AP- Mechlorethamine 0.02% Compounded in Aquaphor |
|---|---|---|
| Started | 130 | 130 |
| Completed | 81 | 86 |
| Not completed | 49 | 44 |
| Withdrew: Adverse event | 26 | 22 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Lack of efficacy | 4 | 4 |
| Withdrew: Lost to follow-up | 4 | 3 |
| Withdrew: Non-compliance | 2 | 3 |
| Withdrew: Concurrent illness | 4 | 3 |
| Withdrew: Subject's best interest | 2 | 2 |
| Withdrew: Various | 4 | 3 |
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
| percentage of participants | PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel | AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02% |
|---|---|---|
| Ratio of Response Rates Based on CAILS | 76 | 62 |
Results for this outcome have not been posted.
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.
| Percent of participants | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor |
|---|---|---|
| Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT) | 61 | 60 |
Collected over adverse event data were collected over 12 months of the patient's participation. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | — | 0/128 (0%) | 108/128 (84.4%) |
| AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | — | 0/127 (0%) | 99/127 (78%) |
| Event | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor |
|---|---|---|
| skin irritationSkin and subcutaneous tissue disorders | 32/128 | 18/127 |
| pruritusSkin and subcutaneous tissue disorders | 25/128 | 20/127 |
| erythemaSkin and subcutaneous tissue disorders | 22/128 | 18/127 |
| dermatitis contactSkin and subcutaneous tissue disorders | 19/128 | 19/127 |
| upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 11/128 | 10/127 |
| skin hyperpigmentationSkin and subcutaneous tissue disorders | 7/128 | 9/127 |
| folliculitisInfections and infestations | 7/128 | 5/127 |
| Age, Categorical(Participants) | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 93 | 86 | 179 |
| >=65 years | 37 | 43 | 80 |
| Age Continuous(years) | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | Total |
|---|---|---|---|
| Mean | 54.7 ± 14.20 | 56.7 ± 14.34 | 55.7 ± 14.28 |
| Sex: Female, Male(Participants) | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | Total |
|---|---|---|---|
| Female | 53 | 53 | 106 |
| Male | 77 | 77 | 154 |
| Region of Enrollment(participants) | PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel | AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor | Total |
|---|---|---|---|
| United States | 130 | 130 | 260 |
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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