Phase 1 - 11 Trial of Pentoxifylline for the Prevention of Transplant - Related Toxicities Following Bone Marrow

Disease relapse and transplant related toxicities have limited the application of bone marrow transplantation (BMT) in the treatment for hematologic malignancies. Because elevated levels of tumor necrosis factor alpha (TNF-a) have been correlated with the development of transplant related complications, we conducted a phase 1-11 trial of pentoxifylline (PTX), a xanthine derivative capable of down-regulating TNF-a production, in patients with hematologic malignancies undergoing BMT. Thirty consecutive adult patients (median age, 34) were entered and received either an allogeneic (n = 26) or autologous (n = 4) BMT. Patients were enrolled at increasing dose levels (1,200, 1,600, and 2,000 mgld) from day -10 through day +lo0 posttransplant. PTX was well tolerated with no significant adverse side effects noted at any of the dose levels administered. The actuarial day 100 survival for these 30 patients was 90% (95% confidence interval 79% to 100%). When compared with a good risk control group, PTX recipients experienced less mucositis