InPOG-HL-19-03

Response-Adapted Management of Childhood Classical Hodgkin Lymphoma (cHL) and Early Response Assessment by Positron Emission and Computerized Tomography (PET-CT) to allow Omission of Radiotherapy in Indian Children with Treated with a Standard of Care Intensified Chemotherapy Regimen.

PI : Dr. Gaurav Narula

Institution : Tata Memorial Hospital, Mumbai

Mail Id :drgauravnarula@gmail.com

About the Study

Evaluates a response-adapted treatment approach in children with Classical Hodgkin Lymphoma (cHL), using early PET-CT scans to guide therapy. The study explores whether radiotherapy can be safely omitted in children who show a good early response to chemotherapy, with the goal of reducing long-term side effects while maintaining effective treatment outcomes.

Aim of the Study

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.

Eligibility Criteria

Inclusion Criteria

Children ≤18 years of age.
Newly diagnosed Biopsy proven cHL.
Adequate response on Early Response Assessment PET-CT after 2 cycles OEPA in baseline bulky disease (to be eligible for randomization in RCT arm).
Written Informed consent approved by local ethics committee from patient ‘s parents or guardia.

Exclusion Criteria

Previous treatment with chemotherapy (except for steroid in case of symptomatic mediastinal mass and pre-enrolment chemotherapy in RCT arm).
Previous immunotherapy or radiotherapy or participation in another investigational trial.
Other malignancies- on previous history or simultaneous.
Severe concomitant diseases (e.g., immunodeficiency) (exclusion only for RCT arm).