Phase II Study of a Single Pegfilgrastim Injection as Adjunct to Chemotherapy to Mobilize Stem Cells into Peripheral Blood of Resistant/Relapsed Lymphoma Patients- ASH Study

The American Society of Haematology (ASH) had its annual meeting earlier this month. Haematologists from around the world gathered at the San Diego Convention Centre to provide a forum for discussing critical issues in haematology. Nearly 20,000 clinicians, scientists, and others attended the four-day meeting, which consisted of an educational program and cutting-edge scientific sessions. The following was one of the presentations given at the meeting.

The primary end point of the study was the successful mobilization of a target cell dose of 2 x 106 CD34+ cells/kg in lymphoma patients receiving ifosfamide, epirubicin and etoposide (IEV) chemotherapy and a fixed dose (6 mg) of pegfilgrastim given as single subcutaneous injection.An open-label phase II study including 25 relapsed or refractory patients (Hodgkin’s disease=4; aggressive non-Hodgkin’s lymphoma=21) was conducted to evaluate the efficacy of pegfilgrastim, in combination with salvage chemotherapy, mobilizing CD34+ stem cells into peripheral blood. Following chemotherapy, all patients had grade 4 neutropenia with a median duration of 1.5 days (1-3).Pegfilgrastim treatment was well tolerated and only 2/25 patients required pain-control medication. CD34+ cells were mobilized in all patients. The median (range) peak value of peripheral blood CD34+cells after IEV chemotherapy and pegfilgrastim was 141/microL (12.8-386) and occurred almost invariably on day +14 (13-16). Twenty three/25 patients underwent a single apheresis to collect a median of 8.7 CD34+cells/Kg (1.8-17.3). Twenty four/25 patients (96%) reached the target cell dose of 2 x 106 CD34+ cells/kg. High concentrations of circulating CD34+ cells (> 50/microL) were observed for several days after the achievement of the peak value. All patients have been transplanted with pegfilgrastim-mobilized CD34+ cells and all of them showed a rapid and sustained engraftment after high-dose chemotherapy.Researchers’ results show that pegfilgrastim as adjunct to chemotherapy is a predictable and highly effective mobilization regimen in lymphoma patients.(Source: American Society of Haematology (ASH): Blood, Volume 104, issue 11, November 16, 2004.)