Description for experts
Primary objective:
To improve rates of complete remission (CR) in HR ALL relapse patients.
Secondary objectives:
Improve rates of event-free survival (EFS) and overall survival (OS)
Improvement in MRD reduction after induction with versus without bortezomib
Evaluation of the toxicity of induction with versus without bortezomib
Evaluation of the efficacy of the consolidation elements with regard to reducing the MRD burden until
to allo-HSCT
Description for laymen
JSON Data
{
"short_title": "IntReALL HR 2010",
"data_mode": "900",
"data_mode_number": "000002455",
"official_title": "Internationale Studie f\u00fcr die Behandlung von Kindern mit R\u00fcckfall einer akuten lymphoblastischen Leuk\u00e4mie (ALL) im Hochrisiko",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "kurativ",
"therapieintervention_value": null,
"therapielinie_value": "rezidiv_haema",
"ctgov_number": null,
"eudract_number": "2012-000810-12",
"general_contact_email": "Kik-dokuteam-hs65@ukdd.de",
"general_contact_phone": "+49 351-4585035",
"hauptpruefer_dd_name": "Tobias D\u00e4britz",
"description_laie_de": "Prim\u00e4res Ziel:\r\nVerbesserung der Raten einer kompletten Remission (CR) bei HR ALL-Rezidiv-Patienten\r\nSekund\u00e4re Ziele:\r\nVerbesserung der Raten des ereignisfreien \u00dcberlebens (EFS) und des Gesamt\u00fcberlebens (OS)\r\nVerbesserung der MRD-Reduktion nach Induktion mit versus ohne Bortezomib\r\nEvaluation der Toxizit\u00e4t der Induktion mit versus ohne Bortezomib\r\nEvaluation der Wirksamkeit der Konsolidierungselemente bez\u00fcglich Reduktion der MRD-Last bis\r\nzur allo-HSZT",
"description_laie_en": null,
"description_expert_de": null,
"description_expert_en": "Primary objective:\r\nTo improve rates of complete remission (CR) in HR ALL relapse patients.\r\nSecondary objectives:\r\nImprove rates of event-free survival (EFS) and overall survival (OS)\r\nImprovement in MRD reduction after induction with versus without bortezomib\r\nEvaluation of the toxicity of induction with versus without bortezomib\r\nEvaluation of the efficacy of the consolidation elements with regard to reducing the MRD burden until\r\nto allo-HSCT",
"rechtsgrundlage_value": null,
"phase_amg_value": null,
"main_cat_id": 14,
"sub_cat_id": 66
}
