NCT01483690 — drugset

Summary

This is a pilot study using decitabine and vorinostat before and during chemotherapy with vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with acute lymphoblastic leukemia (ALL).

Timeline

Start: 2011-12
Primary completion: 2015-07-31
Completion: 2015-07-31

Publications

Burke MJ, Kostadinov R, Sposto R, Gore L, Kelley SM, Rabik C, Trepel JB, Lee MJ, Yuno A, Lee S, Bhojwani D, Jeha S, Chang BH, Sulis ML, Hermiston ML, Gaynon P, Huynh V, Verma A, Gardner R, Heym KM, Dennis RM, Ziegler DS, Laetsch TW, Oesterheld JE, Dubois SG, Pollard JA, Glade-Bender J, Cooper TM, Kaplan JA, Farooqi MS, Yoo B, Guest E, Wayne AS, Brown PA. Decitabine and Vorinostat with Chemotherapy in Relapsed Pediatric Acute Lymphoblastic Leukemia: A TACL Pilot Study. Clin Cancer Res. 2020 May 15;26(10):2297-2307. doi: 10.1158/1078-0432.CCR-19-1251. Epub 2020 Jan 22.
Raetz EA, Bhatla T. Where do we stand in the treatment of relapsed acute lymphoblastic leukemia? Hematology Am Soc Hematol Educ Program. 2012;2012:129-36. doi: 10.1182/asheducation-2012.1.129.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Decitabine	Small molecule	10 mg/m2	Intravenous
Subject	Decitabine	Small molecule	15 mg/m2	Intravenous
Subject	Vorinostat	Small molecule	180 mg/m2	Oral
Background	Dexamethasone	Small molecule	20 mg/m2	Oral
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
Background	Mitoxantrone	Small molecule	10 mg/m2	Intravenous
Background	Pegaspargase	Protein / enzyme biologic	2500 unknown	Intramuscular
Background	Vincristine	Small molecule	1.5 mg/m2	Intravenous

A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

Summary

Timeline

Publications

Drugs

Indications