Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
试验速览
- 阶段
- 2 期
- 入组人数
- 68
- 主要终点
- Time to progression
研究概览
简要总结
The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose TSEBT (12 Gy total) over a period of two weeks. After a 30 day observation period and confirmation that their disease stage has been downgraded to IA or IB, subjects will use Valchlor as a maintenance therapy over the course of one year. The efficacy of Valchlor as a maintenance drug will be followed clinically through Modified Severity Weight Assessment Tool (mSWAT) and percent body surface area measurements (%BSA). Furthermore, subjects will be followed histopathologically through skin biopsies performed at the screening visit, immediately after observation period, one month after the start of the maintenance period, and twelve months after the start of the maintenance period (4 biopsies total).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •≥ 18 years of age
- •Documentation of diagnosis as evidenced by one or more clinical features consistent with Mycosis Fungoides cutaneous T-Cell lymphoma
- •Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with requirements of the study
- •Skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of Mycosis Fungoides by principal investigator
- •Eligible, in the opinion of the investigator, for low dose TSEBT over the course of two weeks.
- •Availability of subject to be observed for up to 18 months post-screening evaluation.
- •Life Expectancy greater than 6 months
排除标准
- •Pregnant or breast-feeding females
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
- •Patients diagnosed with Sezary Syndrome. Sezary Syndrome is equivalent to mycosis fungoides that develops to Stage IVA/B with B2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than Valchlor or TSEBT.
- •Patients who do not have their disease downgrade to stage IA or IB 30 days following low dose TSEBT.
- •Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment
- •Minimum 3 weeks since prior systematic treatment or phototherapy
- •Decisionally-impaired individuals, prisoners, and vulnerable populations
研究组 & 干预措施
TSEBT & mechlorethamine gel 0.016%
All subjects enrolled in the study will receive two weeks of low dose total skin electron beam therapy (TSEBT) (12 Gy total divided into 6 fractions delivered over two weeks) followed by a weekly maintenance mechlorethamine gel 0.016% regimen for one year. The initiation of the mechlorethamine gel regimen is dependent on their disease stage downgrading to IA and IB following low dose TSEBT.
干预措施: Total skin electron beam therapy (TSEBT) (Radiation)
TSEBT & mechlorethamine gel 0.016%
All subjects enrolled in the study will receive two weeks of low dose total skin electron beam therapy (TSEBT) (12 Gy total divided into 6 fractions delivered over two weeks) followed by a weekly maintenance mechlorethamine gel 0.016% regimen for one year. The initiation of the mechlorethamine gel regimen is dependent on their disease stage downgrading to IA and IB following low dose TSEBT.
干预措施: mechlorethamine gel 0.016% (Drug)
结局指标
主要结局
Time to progression
时间窗: One year
To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen.
次要结局
- Response rate (CR and PR)(One year)