Trial reportBlood advances2026
A phase 1b/2 study of ceralasertib, a selective inhibitor of ATR, in patients with relapsed or refractory MDS and CMML.
Trial report in Blood advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03770429 (A Phase Ib Study of AZD6738 for Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Progressing on Front-Line Therapy), which is not on this map. Not yet cited in PubMed.
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A Phase Ib Study of AZD6738 for Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Progressing on Front-Line Therapy
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Authors and funding
20 authors.
Funding
Abstract
abstractPre-mRNA splicing gene mutations in myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) induce R-loops, which trigger ataxia telangiectasis and Rad3-related kinase (ATR). We studied ceralasertib, an orally bioavailable ATR inhibitor, in adults with relapsed or refractory (R/R) MDS or CMML in a phase 1b/2 study 160mg twice daily during 28-day cycles on 2 dosing schedules: days 1 to 14 (14on/14off) or days 1-7 and 15-21 (7on/7off). Response rates and survival were estimated. Forty-four evaluable patients were treated. Grade ≥3 adverse events included thrombocytopenia (n = 13), anemia (n = 12), neutropenia (n = 9), febrile neutropenia (n = 9), pneumonia (n = 6), and hypoxia (n = 5). Thrombocytopenia requiring a platelet transfusion during the first cycle was reduced to 1 of 10 patients on 7on/7off compared with 8/16 patients on 14on/14off among patients with a baseline platelet count >50 × 109/L (P = .087). Overall response rate (ORR) was 29.5% (13/44 patients) and included 1 complete response (CR), 5 marrow CR (2 with hematologic improvement [HI] in neutrophils [HI-N]), and 7 with HI (HI in erythroid/red cells, n = 4; HI-N, n = 2; HI in platelets, n = 1). Median progression-free survival (PFS) was 4.8 months, and overall survival (OS) was 12 months. ORR (P = .72), PFS (P = .9), and OS (P = .65) did not differ between schedules. Splicing factor mutation variant allele frequencies (VAFs) remained stable while RUNX1 mutation VAFs typically increased at progression. Serum inflammatory cytokine levels (TNFRSF8 [CD30], TNF family members) decreased during ceralasertib exposure; this effect was blunted in RUNX1-mutant samples. Ceralasertib 160 mg twice daily on days 1-7 and 15-21 was established as monotherapy dosing. This trial was registered at www.clinicaltrials.gov as NCT03770429.
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