BL-8040 Addition to Consolidation Therapy in AML Patients

Summary

This study evaluates the addition of BL-8040 to the standard consolidation therapy with cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants will receive BL-8040 and cytarabine in combination, while the other half will receive placebo and cytarabine.

Timeline

Start

2015-09

Primary completion

2018-07

Completion

—

Outcome

Missed primary endpoint

paper Median relapse-free survival did not substantially differ between groups: 10.3 months (95% confidence interval [CI], 8.0-12.0) for motixafortide PMID 41980027 ↗

paper for placebo (log-rank P = .98). PMID 41980027 ↗

Publications

• Ceran E, Jaramillo S, Merbach AK, Rohde C, Wass M, Schaffrath J, Durruthy-Durruthy R, Arribas-Layton M, Sciambi A, Rieger K, Nogai A, Hanel M, Herbst RT, Stolzel F, Rollig C, Jost E, Schlenk R, Lotze M, Noppeney R, Brandts CH, Krug U, Gotze KS, Buske S, Florschutz A, Schubert JEA, Opitz B, Esseling E, von Witzendorff S, Subklewe M, Kaufmann M, Frickhofen N, Scholz CW, Schafer-Eckart K, Kunzmann V, Schmidt-Hieber M, Sayer HG, Rank A, Hemmati PG, Schuler F, Scheller M, Kowoll S, Steighardt J, Edemir B, Ludwig-Kraus B, Mueller LP, Edemir S, Vainstein-Haras A, Sorani E, Gliko-Kabir I Mrs, Kadosh S, Tavor S, Gromann C, Wienke A, Bauer M, Wickenhauser C, Baldus CD, Platzbecker U, Cerwenka A, Serve H, Bornhauser M, Junghanss C, Muller-Tidow C. Inhibition of high CXCR4 with Motixafortide and absence of single-cell MRD predict outcome after AML consolidation. Blood. 2026 Apr 14:blood.2025032033. doi: 10.1182/blood.2025032033. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Motixafortide	Peptide	1.25 mg/kg	Subcutaneous
Background	Cytarabine	Small molecule	1 g	Intravenous
Background	Cytarabine	Small molecule	3 g	Intravenous

Indications