Clinical Trial Title

A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma

Trial Summary and Conditions

This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.

Data Summary

N/A

Study Objectives

" Primary: To maintain the overall survival (as defined by 4-year ""second-event"" free survival) for subjects with high risk Hodgkin lymphoma at or above 95%. Secondary: To maintain 3-year event-free survival for subjects with high risk Hodgkin lymphoma at or above 93%; To maintain comparable overall survival (as defined by 4-year ""second-event"" free survival) between subjects with high risk Hodgkin lymphoma who have a rapid or slow response to the initial 2 cycles of ABVE-PC* by intensifying therapy through the addition of 2 cycles of ifosfamide/vinorelbine in those with a slow early response; To investigate whether very early response assessment measured by FDG-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles; To describe the patterns of relapse after ABVE-PC* and risk-adapted radiotherapy"

Outcome Measures

Primary:Second-event-free Survival [Time Frame: At 4 years from enrollment] Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event; Safety Analysis and Monitoring of Toxic Death [Time Frame: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).] The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment. Secondary: Event Free Survival [Time Frame: At 3 years from enrollment] Survival from enrollment to first event: relapse/progression, second malignancy

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

• NCT01026220

NCI Description

NCT01026220-D1 Dataset contains all the data which provides all the numbers, statistics, figures and tables in this publication. The data includes patient demographics, clinical characteristics and survival endpoints. This dataset is presented at patient level and includes one record per patient.