Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML)

Summary

RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II).

Timeline

Start

2012-03

Primary completion

2014-11

Completion

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Publications

• Berdel AF, Koch R, Gerss J, Hentrich M, Peceny R, Bartscht T, Steffen B, Bischoff M, Spiekermann K, Angenendt L, Mikesch JH, Kewitz T, Butterfass-Bahloul T, Serve H, Lenz G, Berdel WE, Krug U, Schliemann C. A randomized phase 2 trial of nintedanib and low-dose cytarabine in elderly patients with acute myeloid leukemia ineligible for intensive chemotherapy. Ann Hematol. 2023 Jan;102(1):63-72. doi: 10.1007/s00277-022-05025-0. Epub 2022 Nov 18.
• Schliemann C, Gerss J, Wiebe S, Mikesch JH, Knoblauch N, Sauer T, Angenendt L, Kewitz T, Urban M, Butterfass-Bahloul T, Edemir S, Vehring K, Muller-Tidow C, Berdel WE, Krug U. A Phase I Dose Escalation Study of the Triple Angiokinase Inhibitor Nintedanib Combined with Low-Dose Cytarabine in Elderly Patients with Acute Myeloid Leukemia. PLoS One. 2016 Oct 7;11(10):e0164499. doi: 10.1371/journal.pone.0164499. eCollection 2016.

Drugs

Indications