Health Condition 1: C749- Malignant neoplasm of unspecifiedpart of adrenal gland
Conditions
Sponsors
Dr Venkata Rama Mohan Gollamudi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children and adults diagnosed with neuroblastoma 2. Receiving anti-GD2 immunotherapy with Dinutuximab-beta for any indication: (a) as maintenance therapy in the primary setting for high-risk disease or (b) as salvage regimen in refractory or relapsed disease
Exclusion criteria
Exclusion criteria: 1. Refusal of consent to participate in the study 2. Incomplete treatment details
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the 3-year EFS in High Risk Neuroblastoma treated with Immunotherapy in primary setting. 2. To assess the overall response rate High Risk Neuroblastoma treated with Immunotherapy modality of salvage in relapse and refractory setting. 3. To evaluate the toxicity profile, tolerance and compliance to the immunotherapy in children with High Risk Neuroblastoma. Timepoint: 1. 3-year EFS: for retrospective study from the date of diagnosis of High Risk Neuroblastoma, for prospective patients patients from the date of relapse or refractory High Risk Neuroblastoma 2. overall response rate: for retrospective study from the date of diagnosis of High Risk Neuroblastoma, for prospective patients patients from the date of relapse or refractory High Risk Neuroblastoma 3. Evaluate the toxicity profile, tolerance and compliance to the immunotherapy in children with High Risk Neuroblastoma: In retrospective patients after consenting during and at the end of immunotherapy and for prospective patients after consenting, during and at the end of immunotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the 3-year OS in children treated with Immunotherapy in both primary and relapsed/ refractory High Risk Neuroblastoma. 2. To evaluate the clinical practices associated with Dinutuximab administration India 3. To analyse the effects of various prognostic factors on relapse/progression after dinutuximab beta immunotherapy in the Indian setting. Timepoint: 1. 3-year OS: for retrospective study from the date of diagnosis of High Risk Neuroblastoma, for prospective patients patients from the date of relapse or refractory High Risk Neuroblastoma 2. To evaluate the clinical practices associated with Dinutuximab administration India: In retrospective patients after consenting, during and at the end of immunotherapy and for prospective patients after consenting, during and at the end of immunotherapy 3. To analyse the effects of various prognostic factors on relapse/progression after dinutuximab beta immunotherapy in the Indian setting: In retrospective patients after consenting, after completion of immunotherapy and for prospective patients after consenting, after completion of immunotherapy | — |
Countries
India
Contacts
Public ContactDr Venkata Rama Mohan Gollamudi
Tata Memorial Hospital
Outcome results
None listed