Prospective Collaborative Study for pulse dexamethasone and lenalidomide in
Relapsed / Refractory Langerhans cell histiocytosis (LENDEX-LCH study)
● Principal Investigator: Dr. Reghu
● To study prospectively the efficacy of pulse dexamethasone and lenalidomide
● (LenDex) in attaining remission in children diagnosed to have refractory/relapsed LCH
● To establish that LenDex is non-inferior to cladribine/cytarabine for treatment of refractory disease
● To determine factors that predict response
● To evaluate safety profile of the combination in children
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
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
Primary
● Response to six cycles of chemotherapy
● Event free survival and Overall Survival for all patients treated as per this protocol
● Adverse effects of the drugs noted during and post treatment
● Correlation of risk factors at the time of enrolment in the study with outcome