A phase 1 trial of temsirolimus and intensive re-induction chemotherapy for 2nd or greater relapse of acute lymphoblastic leukaemia: a Children's Oncology Group study (ADVL1114).

ABSTRACT: The phosphatidylinositol 3-kinase (PI3K)/mammalian (or mechanistic) target of rapamycin (mTOR) signalling pathway is commonly dysregulated in acute lymphoblastic leukaemia (ALL). A phase 1 trial of the mTOR inhibitor temsirolimus in combination with UKALL R3 re-induction chemotherapy was conducted in children and adolescents with second or greater relapse of ALL. The initial temsirolimus dose level (DL1) was 10 mg/m² weekly × 3 doses. Subsequent patient cohorts received temsirolimus 7·5 mg/m² weekly × 3 doses (DL0) or, secondary to toxicity, 7·5 mg/m² weekly × 2 doses (DL-1). Sixteen patients were enrolled, 15 were evaluable for toxicity. Dose-limiting toxicity (DLT) occurred at all three dose levels and included hypertriglyceridaemia, mucositis, ulceration

SUBMITTER: Rheingold SR 

PROVIDER: S-EPMC5403576 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature