Treatment of Relapsed or Refractory Acute Myeloblastic Leukemia

Phase 1/2 Completed 55 enrolled PETHEMA Foundation

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Second-line induction therapy with fludarabine, idarubicin, cytarabine,Granulocyte colony-stimulating factor (G-CSF) and plerixafor, in patients with relapsed or refractory Acute Myeloblastic Leukemia (AML) aged 65 or younger.

Timeline

Start: 2012-07
Primary completion: 2016-05
Completion: 2016-12

Publications

Martinez-Cuadron D, Boluda B, Martinez P, Bergua J, Rodriguez-Veiga R, Esteve J, Vives S, Serrano J, Vidriales B, Salamero O, Cordon L, Sempere A, Jimenez-Ubieto A, Prieto-Delgado J, Diaz-Beya M, Garrido A, Benavente C, Perez-Simon JA, Moscardo F, Sanz MA, Montesinos P; CETLAM and PETHEMA groups. A phase I-II study of plerixafor in combination with fludarabine, idarubicin, cytarabine, and G-CSF (PLERIFLAG regimen) for the treatment of patients with the first early-relapsed or refractory acute myeloid leukemia. Ann Hematol. 2018 May;97(5):763-772. doi: 10.1007/s00277-018-3229-5. Epub 2018 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plerixafor	Small molecule	160 ug/kg	Intravenous
Subject	Plerixafor	Small molecule	240 ug/kg	Intravenous
Subject	Plerixafor	Small molecule	320 ug/kg	Intravenous
Subject	Plerixafor	Small molecule	400 ug/kg	Intravenous
Subject	Plerixafor	Small molecule	480 ug/kg	Intravenous
Background	Cytarabine	Small molecule	2 g	Intravenous
Background	Cytarabine	Small molecule	3 g	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous
Background	Granulocyte colony-stimulating factor	Protein / enzyme biologic	5 ug/kg	Subcutaneous
Background	Idarubicin	Small molecule	10 mg/m2	Intravenous

Treatment of Relapsed or Refractory Acute Myeloblastic Leukemia

Summary

Timeline

Publications

Drugs

Indications