A phase II study of azacitidine in combination with granulocyte-macrophage colony-stimulating factor as maintenance treatment, after allogeneic blood or marrow transplantation in patients with poor-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Issue 13 (10th November 2021)

• Record Type: Journal Article
• Authors: Webster, Jonathan A.; Yogarajah, Meera; Zahurak, Marianna; Symons, Heather; Dezern, Amy E.; Gojo, Ivana; Prince, Gabrielle T.; Morrow, Jillian; Jones, Richard J.; Smith, B. Douglas; Showel, Margaret
• Is Part Of: Leukemia & lymphoma. Volume 62:Issue 13(2021)
• Page Start: 3181
• Page End: 3191
• Publication Date: 2021-11-10
• Subjects: AML -- MDS -- Post-transplant maintenance -- Azacitidine -- GM-CSF; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.1080/10428194.2021.1948029
• Languages: English
• ISSNs: 1042-8194

Abstract

Abstract: Relapse is the most common cause of treatment failure following allogeneic blood or marrow transplantation (alloBMT) for AML or MDS. Post-transplant maintenance therapies may prevent relapse. We conducted a phase II trial combining azacitidine (AZA) with GM-CSF in non-relapsed, post-transplant patients with AML or MDS. Patients received escalating doses of AZA to a maximum of 75 mg/m 2 for 5 days per cycle for up to 12 cycles. GM-CSF was given on days 1–10 of each cycle. Eighteen patients were treated following non-myeloablative (17) and myeloablative (1) alloBMT for AML (61.1%), MDS (27.7%), or therapy-related myeloid neoplasm (11.1%). The majority of patients (72%) received their graft from an HLA-haploidentical donor. The treatment was well-tolerated with rare grade 3–4 hematologic toxicities. One patient suffered an exacerbation of GVHD. The 24-month relapse-free and overall survivals were 47 and 57%, respectively, with a median of 18.6 and 29 months.