drugset / Trial / NCT03817320

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

Phase 1/2 Active not recruiting 24 enrolled Therapeutic Advances in Childhood Leukemia Consortium Children's Hospital Los Angeles · collab Takeda · collab

Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2019-02-12
Primary completion: 2023-12-03
Completion: 2025-06-30

Publications

Schafer ES, Pacenta HL, Chi YY, Malvar J, Doan A, Schore RJ, Rushing T, Leong R, Bujarski S, Gaynon PS, Karol SE, Barredo JC, Rheingold SR, Huynh V, Gossai NP, Chang BH, Slone T, Pauly M, Wayne AS, Bhojwani D, Horton TM. Ixazomib with chemotherapy for childhood relapsed acute lymphoblastic leukemia: a TACL consortium report. Blood Neoplasia. 2026 May 16;3(3):100247. doi: 10.1016/j.bneo.2026.100247. eCollection 2026 Aug.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixazomib	Unknown	1.2 mg/m2	Oral
Subject	Ixazomib	Unknown	1.6 mg/m2	Oral
Subject	Ixazomib	Unknown	2 mg/m2	Oral
Background	Asparaginase Erwinia chrysanthemi	Protein / enzyme biologic	17500 iu	Intravenous
Background	Asparaginase Erwinia chrysanthemi	Protein / enzyme biologic	20000 iu	Intravenous
Background	Asparaginase Erwinia chrysanthemi	Protein / enzyme biologic	25000 iu	Intravenous
Background	Cytarabine	Small molecule	—	Intrathecal
Background	Dexamethasone	Small molecule	3.5 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	4 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	5 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	42 mg/m2	—
Background	Doxorubicin	Other / unclassified	48 mg/m2	—
Background	Doxorubicin	Other / unclassified	60 mg/m2	—
Background	Hydrocortisone	Other / unclassified	—	Intrathecal
Background	Leucovorin	Small molecule	5 mg/m2	Oral
Background	Methotrexate	Small molecule	—	Intrathecal
Background	Pegaspargase	Protein / enzyme biologic	1750 iu	Intravenous
Background	Pegaspargase	Protein / enzyme biologic	2000 iu	Intravenous
Background	Pegaspargase	Protein / enzyme biologic	2500 iu	Intravenous
Background	Vincristine	Small molecule	1 mg/m2	Intravenous
Background	Vincristine	Small molecule	1.2 mg/m2	Intravenous
Background	Vincristine	Small molecule	1.5 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications