A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML

Phase 1 Completed 15 enrolled Therapeutic Advances in Childhood Leukemia Consortium Gateway for Cancer Research · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary treatment or who relapsed.

Timeline

Start: 2013-05-22
Primary completion: 2014-07-28
Completion: 2014-07-28

Publications

Results Sun W, Triche T Jr, Malvar J, Gaynon P, Sposto R, Yang X, Bittencourt H, Place AE, Messinger Y, Fraser C, Dalla-Pozza L, Salhia B, Jones P, Wayne AS, Gore L, Cooper TM, Liang G. A phase 1 study of azacitidine combined with chemotherapy in childhood leukemia: a report from the TACL consortium. Blood. 2018 Mar 8;131(10):1145-1148. doi: 10.1182/blood-2017-09-803809. Epub 2018 Jan 16. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	75 mg/m2	Subcutaneous
Background	Cytarabine	Small molecule	30 mg	Intravenous
Background	Cytarabine	Small molecule	50 mg	Intravenous
Background	Cytarabine	Small molecule	70 mg	Intravenous
Background	Cytarabine	Small molecule	2000 mg/m2	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous
Background	Methotrexate	Small molecule	8 mg	Intrathecal
Background	Methotrexate	Small molecule	10 mg	Intrathecal
Background	Methotrexate	Small molecule	12 mg	Intrathecal
Background	Methotrexate	Small molecule	15 mg	Intrathecal

A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML

Summary

Timeline

Publications

Drugs

Indications