A chemotherapy response adapted management of an intense standard of care treatment regimen of classical Hodgkin Lymphoma in children, where the radiation therapy can be omitted based on the risk assessed through Positron Emission and Computerized Tomography imaging technique

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 Treated with a Standard of Care Intensified Chemotherapy Regimen

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027495

Enrollment

700

Registered

2020-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C811- Nodular sclerosis Hodgkin lymphoma Health Condition 2: C812- Mixed cellularity Hodgkin lymphoma Health Condition 3: C813- Lymphocyte depleted Hodgkin lymphoma Health Condition 4: C814- Lymphocyte-rich Hodgkin lymphoma Health Condition 5: C817- Other Hodgkin lymphoma Health Condition 6: C819- Hodgkin lymphoma, unspecified

Interventions

Intervention1: RCT Arm: Arm-A: For patients enrolled on the study, the decision on radiotherapy to baseline bulky sites will be based on response in PET-CT scan. In arm A, there will be no administrat

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children less than or equal to 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 patientâ??s parents or guardian

Exclusion criteria

Exclusion criteria: 1.Previous treatment with chemotherapy (except for steroid in case of symptomatic mediastinal mass,and pre-enrollment 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 (eg. immunodeficiency) (exclusion only for RCT arm)

Design outcomes

Primary

Measure	Time frame
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.Timepoint: Randomization, progression/relapse, secondary malignancy, death, last date of follow-up to be recorded till 3 years from the day of last randomized patient in RCT arm	—

Measure

Time frame

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.Timepoint: Randomization, progression/relapse, secondary malignancy, death, last date of follow-up to be recorded till 3 years from the day of last randomized patient in RCT arm

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Secondary

Measure	Time frame
The secondary endpoint is Overall survival, which will be calculated from the date of randomization to death due to any cause, or last follow up in the RCT arm. In the descriptive arm, Overall survival will be calculated from the date of start of chemotherapy to death due to any cause or last follow up.Timepoint: Start of Chemotherapy, death, last date of follow-up to be recorded till 3 years from the day of last randomized patient in RCT arm	—

Measure

Time frame

The secondary endpoint is Overall survival, which will be calculated from the date of randomization to death due to any cause, or last follow up in the RCT arm. In the descriptive arm, Overall survival will be calculated from the date of start of chemotherapy to death due to any cause or last follow up.Timepoint: Start of Chemotherapy, death, last date of follow-up to be recorded till 3 years from the day of last randomized patient in RCT arm

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Countries

India

Contacts

Public ContactDr Gaurav Narula

Tata Memorial Hospital

drgauravnarula@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026