Prospective Collaborative Study for pulse dexamethasone and lenalidomide in Relapsed / Refractory Langerhans cell histiocytosis (LENDEXLCH study)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Response to six cycles of chemotherapy
研究概览
简要总结
Relapsed / refractory Langerhans cell histiocytosis(LCH) has been known to have a guarded prognosis. Salvage chemotherapyprotocols can be expensive with significant toxicity and increased risk ofmorbidity and mortality. A combination of pulse dexamethasone and lenalidomideis a cost-effective outpatient-based protocol which has been derived based onthe underlying pathophysiology of LCH. The proposed protocol includes sixcycles of the oral combination as a salvage treatment option for relapsed /refractory LCH.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients from 1 year of age to 18 years of age with biopsy proven LCH 2.Relapsed or refractory disease after having received 6 to 12 weeks of induction chemotherapy with Vinblastine plus prednisolone as per LCH II or III protocol 3.Relapsed or refractory disease after receiving salvage chemotherapy with cladribine +/- cytarabine can also be included 4.Patients with low-risk disease at the time of relapse may be offered LenDex upfront 5.Patients with high-risk disease at the time of relapse may be offered LenDex upfront or after salvage treatment, based on the discretion of the treating physician.
排除标准
- •1.Pregnancy or lactation 2.Patients with renal impairment defined as a serum creatinine > 1 3.Patients with liver impairment (excluding those due to disease) defined as SGPT and/or PT more than 5 times the upper limit of normal 4.Patients with pre-existing peripheral neuropathy.
结局指标
主要结局
1.Response to six cycles of chemotherapy
时间窗: EVERY 3 MONTHS FOR THE FIRST 2 YEARS | EVERY 6 MONTHS FOR THE NEXT 2 YEARS
2.Event free survival and Overall Survival for all patients treated as per this protocol
时间窗: EVERY 3 MONTHS FOR THE FIRST 2 YEARS | EVERY 6 MONTHS FOR THE NEXT 2 YEARS
3.Adverse effects of the drugs noted during and post treatment
时间窗: EVERY 3 MONTHS FOR THE FIRST 2 YEARS | EVERY 6 MONTHS FOR THE NEXT 2 YEARS
4.Correlation of risk factors at the time of enrolment in the study with outcome
时间窗: EVERY 3 MONTHS FOR THE FIRST 2 YEARS | EVERY 6 MONTHS FOR THE NEXT 2 YEARS
次要结局
- Cost-effectiveness of the combination LenDex(Every 6 months for 2 years)