Response-Adapted Management of Childhood Classical Hodgkin Lymphoma (cHL) and Early Response Assessment by Positron Emission and Computerised Tomography (PET-CT) to allow Omission of Radiotherapy in Indian Children with Treated with a Standard of Care Intensified Chemotherapy Regimen.
● Principal Investigator: Dr. Gaurav Narula
● RCT arm: Primary objective is the feasibility of elimination of RT in childhood cHL with bulky disease and adequate response on early PET-CT based response assessment after 2 cycles OEPA by looking at Event free survival.
● Descriptive arm: Primary objective is to assess the Event free survival of cHL treated on standard risk-adapted protocols across multiple paediatric oncology centres in India
1. Children ≤18 years of age
2. Newly diagnosed Biopsy proven cHL
3. Adequate response on Early Response Assessment PET-CT after 2 cycles OEPA in
baseline bulky disease (to be eligible for randomization in RCT arm)
4. Written Informed consent approved by local ethics committee from patient ‘s parents or guardian
1. Previous treatment with chemotherapy (except for steroid in case of symptomatic
mediastinal mass and pre-enrolment chemotherapy in RCT arm).
2. Previous immunotherapy or radiotherapy or participation in another investigational trial
3. Other malignancies- on previous history or simultaneous
4. Severe concomitant diseases (e.g., immunodeficiency) (exclusion only for RCT arm)
● The primary endpoint is Event free survival, which is calculated from the date of randomization to relapse, progression, death and occurrence of second malignant neoplasm or last follow up in the RCT arm. In the descriptive arm, Event free survival will be calculated from the date of start of chemotherapy to event or last follow up.