TACL'ing supportive care needs in pediatric early phase clinical trials for acute leukemia: A report from the therapeutic advances in childhood leukemia & lymphoma (TACL) consortium supportive care committee.

A Supportive Care Committee was recently developed within the Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) Consortium. This was substantiated by the significantly high rate of serious adverse events (SAE) (CTCAE Grade ≥3 toxicity) experienced by patients with relapse/refractory acute leukemia enrolled on our phase I trials. Such treatment-related toxicity has resulted in patients being removed from study and thus potentially not receiving clinical benefit from the novel therapy. In addition, increased treatment-related toxicity may compromise new agents from moving forward in their clinical development. To address these challenges, TACL initiated a Supportive Care Committee to help mitigate the treatment-related toxicity risk that exists in heavily pre-treated patients with relapse/refractory leukemia. This manuscript reviews the mission of the TACL Supportive Care Committee presented at the 2016 TACL Investigators' Meeting (Los Angeles, CA) and the future direction in providing enhanced supportive care guidelines for all TACL studies.