drugset / Trial / NCT03888534

Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy)

NCT03888534

Non-randomizedSequentialOpen-labelOther

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), safety and toxicity, and pharmacokinetics (PK) of ixazomib administered intravenously in combination with multiagent reinduction chemotherapy in pediatric participants with relapsed/refractory ALL or LLy.

Timeline

Start
2020-10-31
Primary completion
2022-08-30
Completion
2022-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ixazomib Unknown 0.03 mg/kg Intravenous
Subject Ixazomib Unknown 1 mg/m2 Intravenous