During the plenary session at the American Society of Hematology's (ASH) Annual Meeting on December 6, 2015, in Orlando, Fla., presenter Sébastien Maury, MD, PhD, had good news for the crowd anticipating the results of a multicenter trial.
Building on the knowledge that rituximab (Rituxin) improves treatment of B-cell non-Hodgkin lymphoma, including Burkitt lymphoma and leukemia, Dr. Maury, Hôpital Henri Mondor, Créteil, France, and a team of researchers from several centers in Europe developed a phase III study to see whether adding the monoclonal antibody to intenstive standard therapy would improve outcomes in other malignancies.
“We are seeing how scientific discoveries in the lab are translating into real, positive clinical impact. Patients, especially those with challenging diseases, can be heartened by the tremendous expansion of options and new therapeutic approaches,” said Gary Schiller, MD, Professor of Medicine in the Division of Hematology/Oncology at the University of California, Los Angeles School of Medicine, in an official ASH press release.
The GRAALL-R 2005 is a randomized study evaluating the role of rituximab in patients with Ph-negative, B-cell precursor acute lymphoblastic leukemia (BCP-ALL). This trial is based on the successful GRAAL trial in pediatric cancers.
The team enrolled 220 patients, ages 18-59 with newly diagnosed, and previously untreated, CD20-positive Ph-negative BCP-ALL. CD20—a protein found on the surface of many blood cancer cells—is present in 30% to 50% of patients with BCP-ALL, a type of leukemia that is common in children, but also affects adults. Approximately 32% of adults with Ph-negative, BCP-ALL have CD20-positive ALL.
The patients received rituximab (375 mg/m2) during induction (day 1 and 7), salvage reinduction when needed (day 1 and 7), consolidation blocks (6 infusions), late intensification (day 1 and 7), and first year of maintenance (6 infusions) for a total of 16 to 18 infusions. Allogeneic stem cell transplantation (SCT) was offered in first complete remission (CR) to patients with one or more conventional high-risk criteria and a donor. The primary study objective was event-free survival (EFS).
With a median follow-up of 30 months, patients treated in the rituximab arm had a lower cumulative incidence of relapse—taking into account other factors impacting EFS such as age, central nervous system involvement, and white blood cell count at diagnosis.
During the ASH presentation, Dr. Maury concluded that adding rituxumab to standard intensive chemotherapy is well-tolerated, significantly improves EFS, and prolongs overall survival in patients not receiving allogeneic stem cell transplanation in first CR. He recommends adding rituxumab to chemotherapy as the standard of care, but cautions that the optimal dose schedule administered remains to be determined.