Fludarabine vs cladribine plus busulfan and low-dose TBI as reduced intensity conditioning for allogeneic hematopoietic stem cell transplantation: A prospective randomized trial

M. Markova, J. N. Barker, J. S. Miller, M. Arora, J. E. Wagner, L. J. Burns, M. L. MacMillan, D. Douek, T. DeFor, Y. Tan, T. Repka, B. R. Blazar, D. J. Weisdorf

Research output: Contribution to journalArticle

13 Scopus citations

Abstract

Purine analogs are often used for conditioning preceding allogeneic hematopoietic stem cell transplantation (HCT). We prospectively tested fludarabine (Flu) 40mg/m2/day × 5 days vs cladribine (Clad) 10mg/m2/day × 5 days plus oral busulfan (1mg/kg q6h × 2 days) and total body irradiation 200 cGy in 32 recipients of matched sibling and unrelated donor (URD) HCT. Patients were similar in age (median 52 years), diagnosis, extensive pre-HCT therapy (56 vs 63%), and high-risk disease status (81 vs 93%). Neutrophil engraftment was prompt (median 11 vs 12 days), but early graft failure using Clad halted randomization. Platelet recovery was prompt (median Flu 18 vs Clad 24 days). Graft-versus-host disease (GVHD) after Flu vs Clad was similar; (acute grade II/IV 56 vs 69%, P = 0.26; chronic 50 vs 31%, P = 0.27). Nonrelapse mortality (Flu 25 vs Clad 38%, P = 0.47) and progression-free survival at 3 years were similar as well. Multivariate analyses showed slightly, but not significantly lower relative risk (RR) of neutrophil engraftment with Clad (RR 0.6 (95% CI 0.2-1.3) P = 0.16) and with URD RR 0.4 (0.2-1.0) P = 0.04). Older patients with advanced hematologic malignancies achieve satisfactory outcomes using either of these reduced intensity conditioning regimens.

Original languageEnglish (US)
Pages (from-to)193-199
Number of pages7
JournalBone marrow transplantation
Volume39
Issue number4
DOIs
StatePublished - Feb 1 2007

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