[601] A Phase III, Multicenter, Randomized, Double-Blind, Placebo Controlled, Comparative Trial of AMD3100 (Plerixafor)+G-CSF vs. Placebo+G-CSF in Non-Hodgkins Lymphoma (NHL) Patients for Autologous Hematopoietic Stem Cell (aHSC) Transplantation. Session Type: Oral Session

John F. DiPersio, Ivana Micallef, Patrick J. Stiff, Brian J. Bolwell, Richard Thomas Maziarz, J. Angell, G. Bridger, Gary Calandra, 3101 Investigators Washington University, St. Louis, MO, USA; Mayo Clinic, Rochester, MN, USA; Loyola University, Chicago, IL, USA; Cleveland Clinic, Cleveland, OH, USA; Oregon Health Science University, Portland, OR, USA; Genzyme Corporation, Cambridge, MA, USA

AMD3100, Plerixafor (A)+G-CSF (G) have safely and effectively allowed aHSC mobilization in Phase I and II studies. This Phase III, multicenter, randomized, double-blind, placebo controlled study compared the safety and efficacy of A+G versus Placebo (P)+G to mobilize and transplant patients with NHL. Methods: Adult NHL patients requiring an aHSC transplant, in first or second CR or PR were eligible to participate. Patients received G (10g/kg/day) subcutaneously (SQ) for 4 days. On the evening of Day 4, patients received either A (240g/kg SQ) or P. Patients underwent apheresis on Day 5 after an AM dose of G and 10-11 hours after administration of study treatment. Patients continued to receive the evening dose of study treatment, followed by AM dose of G and apheresis for up to a total of 4 aphereses or until 5 x 10⁶ CD34+cells/kg were collected. Only study cells were used for transplant. Patients who failed to mobilize 2 x 10⁶ CD34+cells/kg could enter into a rescue arm of A+G, without unblinding of randomized treatment. The primary endpoint was the percentage of patients who achieved 5 x 10⁶ CD34+cells/kg in 4 or less aphereses days. All patients will be followed for 12 months post-transplant. Results: 298 patients were enrolled and randomized. All patients have completed 100 days follow-up and are included in this intent-to-treat analysis. Baseline characteristics were similar between groups. The primary endpoint was met in 89/150 (59%) patients in the A+G group and 29/148 (20%) patients in the P+G group, p<0.0001. 130/150 (87%) patients in the A+G group and 70/148 (47%) patients in the P+G group collected 2 x 10⁶ CD34+cells/kg in 4 or less aphereses days, p<0.0001.

The figure shows that more patients in the A+G group reached target after 1 day of apheresis than patients in the P+G group after 4 days of apheresis. A+G rescue was successful in 33/52 rescue patients in the P+G group and 4/10 rescue patients in the A+G group. 135 patients (90%) in A+G group and 82 patients (55%) in P+G group underwent transplantation. Median time to engraftment was Day 10 for PMN and Day 20 for platelets in both groups. Through 100 days, grafts were durable in all but 2 A+G (133/135) patients and in all P+G (82) patients. A+G patients experienced a higher incidence of GI effects (mild to moderate) and injection site erythema than P+G patients. There were 2 drug related serious adverse events in the A+G group and 1 in the P+G group. Conclusions: In this study, the addition of AMD3100 to G-CSF is generally safe and well tolerated and is superior to G-CSF alone for aHSC mobilization in NHL patients. A+G patients were statistically significantly more likely to achieve target cell collection quicker and to achieve sufficient cells for successful transplant than P+G patients.
Abstract #601 appears in Blood, Volume 110, issue 11, November 16, 2007
Keywords: AMD3100|Non-Hodgkin Lymphoma|Mobilization
Disclosure: Research Funding: Genzyme Corporation. Honoraria Information: AnorMED, Genzyme, MGI Pharma.

Monday, December 10, 2007 3:30 PM

Session Info:  Simultaneous Session: Autologous Transplantation: Clinical Results (3:30 p.m.-5:00 p.m.)