Guest Editor(s)
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- Fatih M. Uckun, MD, PhD
- Vice President and Clinical Strategy Lead, Hematology-Oncology, Worldwide Clinical Trials, Morrisville, NC, USA.
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Special Issue Introduction
There is an unmet and urgent need to improve the survival outcomes of adolescents and young adults with cancer. The recently published 2019 Guidance from FDA, "Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials" in the US can be viewed as a strong endorsement of the ACCELERATE proposal regarding inclusion of adolescent patients in adult early-phase clinical drug trials in Europe. Major efforts have been launched by cancer centers to improve the access of their adolescent and young adult cancer patient populations to clinical trials. More recently, there has been an effort to initiate early phase trials of targeted therapies in children and adolescents with cancer. For example, umbrella trial initiatives aimed at allowing children and adolescents with relapsed or refractory pediatric cancers early access to promising targeted precision medicines such as the NCT03155620 Children's Oncology Group (COG)-NCI Pediatric MATCH (Molecular Analysis for Therapy Choice) trial "Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)" have provided a unique opportunity for new therapeutic innovations through mechanistic hypothesis-driven studies.
The primary purpose of this specific topic issue is to collect new and transforming information regarding the currently available therapeutic options as well as clinical trial landscape for adolescents and young adults with cancer. We are particularly interested in papers on precision medicines with a well-defined and preferably unique mechanism of action that show a high clinical impact potential. Manuscripts detailing proof of concept studies in clinical settings are particularly welcome. Novel adaptive designs for hybrid adolescent-adult trials are of interest. The rapid dissemination of the insights and lessons learned from clinical studies involving adolescents and adults with hematologic malignancies or solid tumors may provide the basis for new and effective standard of care regimens that are urgently needed.
Submission Deadline
31 May 2022