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- Title
A phase I/II study of oral clofarabine plus low-dose cytarabine in previously treated acute myeloid leukaemia and high-risk myelodysplastic syndrome patients at least 60 years of age.
- Authors
Buckley, Sarah A.; Mawad, Raya; Gooley, Ted A.; Becker, Pamela S.; Sandhu, Vicky; Hendrie, Paul; Scott, Bart L.; Wood, Brent L.; Walter, Roland B.; Smith, Kelly; Dean, Carol; Estey, Elihu H.; Pagel, John M.
- Abstract
Outcomes for older adults with acute myeloid leukaemia ( AML) and myelodysplastic syndrome ( MDS) are generally poor, and new effective therapies are needed. We investigated oral clofarabine combined with low-dose cytarabine (LDAC) in patients aged 60 years and above with relapsed or refractory AML or high-risk MDS in a phase I/ II trial. A 3 + 3 dose escalation of oral clofarabine was followed by a phase II expansion with the aim of obtaining a complete response ( CR) rate ≥30%. We identified 20 mg/d for 5 d as the maximum tolerated dose ( MTD) of oral clofarabine. A total of 35 patients, with a median age of 72 years, were treated. Of 26 patients enrolled at the MTD, 4 had treatment-related grade 3-4 non-haematological toxicities, but none died within 28 d. The observed CR rate and median survival were 34% [95% confidence interval ( CI), 18-50%] and 6·8 months overall and 38% [95% CI, 19-57%] and 7·2 months at the MTD. The median disease-free survival was 7·4 months. Fifty-two percent (23/44) of cycles administered at the MTD were done without hospital admission. This combination of oral clofarabine and LDAC demonstrated efficacy with a CR rate of >30% and acceptable toxicity in older patients.
- Subjects
LEUKEMIA treatment; MYELOID leukemia; ORAL medication; MYELODYSPLASTIC syndromes; CHILDHOOD cancer; NUCLEOSIDES; HEALTH outcome assessment; DISEASE risk factors
- Publication
British Journal of Haematology, 2015, Vol 170, Issue 3, p349
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/bjh.13437