Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction

Summary

The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. This evaluation will follow a hierarchical testing procedure: each experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.

Timeline

Start

2018-10-01

Primary completion

2023-08-28

Completion

2024-03-28

Outcome

Outcome not reported

Stopped: “The Sponsor has been notified of an interruption in the international supply, and there is a possibility that 131I-mlBG would be unavailable to patients randomised to arm A of the trial”

Drugs

Indications