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

Bone Marrow Transplant. 2007 Feb;39(4):193-9. doi: 10.1038/sj.bmt.1705556. Epub 2007 Jan 15.

Abstract

Purine analogs are often used for conditioning preceding allogeneic hematopoietic stem cell transplantation (HCT). We prospectively tested fludarabine (Flu) 40 mg/m(2)/day x 5 days vs cladribine (Clad) 10 mg/m(2)/day x 5 days plus oral busulfan (1 mg/kg q6 h x 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antineoplastic Combined Chemotherapy Protocols
  • Bone Marrow Transplantation / methods*
  • Busulfan / administration & dosage*
  • Cladribine / administration & dosage*
  • Combined Modality Therapy
  • Female
  • Graft Survival / drug effects
  • Graft vs Host Disease / prevention & control
  • Hematologic Neoplasms / therapy
  • Hematopoietic Stem Cell Transplantation / methods*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Myeloablative Agonists / administration & dosage*
  • Neoplasm Recurrence, Local / prevention & control
  • Prospective Studies
  • Transplantation Conditioning / adverse effects
  • Transplantation Conditioning / methods*
  • Transplantation, Homologous / adverse effects
  • Transplantation, Homologous / methods
  • Vidarabine / administration & dosage
  • Vidarabine / analogs & derivatives*
  • Whole-Body Irradiation

Substances

  • Myeloablative Agonists
  • Cladribine
  • Vidarabine
  • Busulfan
  • fludarabine