Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML

Phase 1 Completed 11 enrolled Washington University School of Medicine

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the investigational drug Midostaurin in various doses given with ATRA and CLAG chemotherapy. Midostaurin is a FLT3 inhibitor that is activated or overexpressed in a significant proportion of AML patients. Research has shown that midostaurin and drugs like midostaurin may work better in combination with chemotherapy, like CLAG. CLAG is a combination of cladribine, cytarabine, and G-CSF which is approved by the FDA and used to treat AML.

Timeline

Start: 2010-11
Primary completion: 2011-08
Completion: 2012-08

Publications

Ramsingh G, Westervelt P, McBride A, Stockerl-Goldstein K, Vij R, Fiala M, Uy G, Cashen A, Dipersio JF, Abboud CN. Phase I study of cladribine, cytarabine, granulocyte colony stimulating factor (CLAG regimen) and midostaurin and all-trans retinoic acid in relapsed/refractory AML. Int J Hematol. 2014 Mar;99(3):272-8. doi: 10.1007/s12185-014-1503-4. Epub 2014 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midostaurin	Small molecule	25 mg	Oral
Subject	Midostaurin	Small molecule	50 mg	Oral
Background	Cladribine	Small molecule	5 mg/m2	Intravenous
Background	Cytarabine	Small molecule	2 mg/m2	Intravenous
Background	Tretinoin	Small molecule	15 mg/m2	Oral
Background	filgrastim	Protein / enzyme biologic	300 ug	Subcutaneous

Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML

Summary

Timeline

Publications

Drugs

Indications