Health Condition 1: C960- Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis
Conditions
Interventions
Intervention1: PULSE DEXAMETHASONE AND LENALIDOMIDE: THE COMBINATION IS GIVEN FOR SIX CYCLES WITH EACH CYCLE FOR 28 DAYS. LENALIDOMIDE IS GIVEN FOR 21/28 DAYS, PULSE DEXAMETHASONE ONCE A WEEK
Control
Sponsors
RAMYA UPPULURI
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Response to six cycles of chemotherapy 2. Event free survival and Overall Survival for all patients treated as per this protocol 3. Adverse effects of the drugs noted during and post treatment 4. Correlation of risk factors at the time of enrolment in the study with outcome Timepoint: EVERY 3 MONTHS FOR THE FIRST 2 YEARS EVERY 6 MONTHS FOR THE NEXT 2 YEARS | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness of the combination LenDexTimepoint: Every 6 months for 2 years | — |
Countries
India
Contacts
Public ContactRAMYA UPPULURI
APOLLO HOSPITALS
Outcome results
None listed