PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Active:	No
Cancer Type:	Leukemia	NCT ID:	NCT03817320
Trial Phases:	Phase I Phase II	Protocol IDs:	T2017-002 (primary) NCI-2019-03049
Eligibility:	1 - 21 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Therapeutic Advances in Childhood Leukemia Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT03817320

Summary

This is a phase 1/2 study of a drug called Ixazomib in combination with cytotoxic
chemotherapy consisting of Vincristine, Dexamethasone, Asparaginase, and Doxorubicin (VXLD).

Objectives

The phase 1 study is to determine the maximum tolerated dose (MTD) of the PO formulation,
followed by a screening phase 2 study to investigate the efficacy of ixazomib in combination
with chemotherapy in children with relapsed ALL and lymphoblastic lymphoma (LLy). The single
arm, screening phase 2 design will allow us to use a minimal number of patients to obtain
preliminary information about treatment efficacy. Discovering a safe and tolerable dose of
ixazomib in a PO formulation and the preliminary efficacy data will significantly increase
the possibility of ixazomib moving forward in frontline pediatric treatment protocols in both
intense chemotherapy courses and maintenance courses.

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