Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)

Summary

Assessment of efficacy of azacitidine to prevent a relapse

Timeline

Start

2011-09

Primary completion

2018-08

Completion

2021-02

Outcome

Met primary endpoint

paper The primary end point was met; 60 (63%) patients were relapse free (95% confidence interval, 54-71; P< .0001) 6 months after azacitidine initiation PMID 41359791 ↗

Publications

• Results Platzbecker U, Middeke JM, Sockel K, Herbst R, Wolf D, Baldus CD, Oelschlagel U, Mutherig A, Fransecky L, Noppeney R, Bug G, Gotze KS, Kramer A, Bochtler T, Stelljes M, Groth C, Schubert A, Mende M, Stolzel F, Borkmann C, Kubasch AS, von Bonin M, Serve H, Hanel M, Duhrsen U, Schetelig J, Rollig C, Kramer M, Ehninger G, Bornhauser M, Thiede C. Measurable residual disease-guided treatment with azacitidine to prevent haematological relapse in patients with myelodysplastic syndrome and acute myeloid leukaemia (RELAZA2): an open-label, multicentre, phase 2 trial. Lancet Oncol. 2018 Dec;19(12):1668-1679. doi: 10.1016/S1470-2045(18)30580-1. Epub 2018 Nov 12.
• Platzbecker AS, Georgi JA, Middeke JM, Sockel K, Wehner R, Herbst R, Wolf D, Baldus CD, Oelschlagel U, Mutherig A, Fransecky L, Noppeney R, Bug G, Gotze KS, Kramer A, Bochtler T, Stelljes M, Esseling E, Stolzel F, von Bonin M, Serve H, Hanel M, Duhrsen U, Harig A, Muller-Tidow C, Schetelig J, Stasik S, Rollig C, Ehninger G, Kramer M, Schmitz M, Bornhauser M, Platzbecker U, Thiede C. Azacitidine to treat measurable residual disease in patients with MDS/AML: final long-term results of the RELAZA2 trial. Blood. 2026 Mar 5;147(10):1098-1110. doi: 10.1182/blood.2025030816.

Drugs

Indications