Panobinostat in Combination With Idarubicin and Cytarabine in Patients Aged 65 Years or Older With Newly Diagnosed Acute Myeloblastic Leukaemia (AML)

Phase 1/2 Completed 46 enrolled PETHEMA Foundation

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This protocol is a multicenter, national, open-label, single-arm, non-controlled study designed to establish the efficacy (in terms of response and survival) and safety of panobinostat in combination with idarubicin and cytarabine and in monotherapy in patients with newly-diagnosed AML aged 65 years or older.

Timeline

Start: 2009-09
Primary completion: 2016-05
Completion: 2018-12

Publications

Ocio EM, Herrera P, Olave MT, Castro N, Perez-Simon JA, Brunet S, Oriol A, Mateo M, Sanz MA, Lopez J, Montesinos P, Chillon MC, Prieto-Conde MI, Diez-Campelo M, Gonzalez M, Vidriales MB, Mateos MV, San Miguel JF; PETHEMA Group. Panobinostat as part of induction and maintenance for elderly patients with newly diagnosed acute myeloid leukemia: phase Ib/II panobidara study. Haematologica. 2015 Oct;100(10):1294-300. doi: 10.3324/haematol.2015.129577. Epub 2015 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Panobinostat	Small molecule	10 mg	Oral
Subject	Panobinostat	Small molecule	20 mg	Oral
Subject	Panobinostat	Small molecule	30 mg	Oral
Subject	Panobinostat	Small molecule	40 mg	Oral

Panobinostat in Combination With Idarubicin and Cytarabine in Patients Aged 65 Years or Older With Newly Diagnosed Acute Myeloblastic Leukaemia (AML)

Summary

Timeline

Publications

Drugs

Indications