Autologous Transplant Using Dose-Escalated Total Body Irradiation & Cyclophosphamide & Palifermin for NHL

Study Summary

Most participants with a relapsed or refractory non-Hodgkin's lymphoma that receive an autologous transplant are likely to suffer a relapse because standard myeloablative preparative regimens are unable to produce a cure. The majority of these participants do not have a stem cell donor available, are too frail to undergo an allogeneic transplant, or refuse an allograft. Historically these participants with high risk non-Hodgkin's lymphoma have had a very poor outcome. To take advantage of the low transplant related mortality associated with an autologous transplantation, the investigators propose modifying the preparative regimen to make it more effective without increasing toxicity. By increasing the dose of radiation while administering the protective growth factor palifermin (Kepivance), the investigators hope to decrease the risk of relapse without increasing transplant related mortality. Three prospective randomized trials have studied different radiation schemes as a part of the TBI and cytoxan preparative regimen prior to allogeneic transplantation for patients with AML or CML. As a group these trials showed that higher doses of TBI in these older studies decreased the risk of relapse at the expense of VOD, GVHD, and CMV. Three retrospective studies have also postulated that higher dose radiation led to less risk of relapse.

Primary Outcome

Any grade 3 or 4 dose limiting toxicities as described : • Heart failure with only minor response to medical therapy * Hemorrhagic cystitis with frank blood requiring sclerosing agent or other surgical procedure * Acute kidney failure requiring dialysis * Interstitial pneumonitis requiring ventilatory support or FiO2 \> 50% x 24hrs * Bilirubin \> 20 mg/dL * Unexplained seizures or coma * Severe mucositis requiring intubation for airway protection * Ileus requiring nasogastric decompression. * D

Interventions

• RADIATION Total body irradiation