You need to clarify the following :

Affiliation of researchers

Sample size calculation and numbers (200 or 222)  

Dates of study start and Gannt chart

Duration of study : revision of records for one month or follow up of patients after six months of giving immunotherapy ?

Are you going to recruit the patients ? if yes modify informed consent

you mentioned study discontinuation and side effects of drugs

Starting by age of 3 this a vulnerable group