Adding rituximab to standard chemotherapy in younger adult patients with Philadelphia chromosome-negative, CD-20-positive B-lineage acute lymphoblastic leukemia significantly prolonged event-free survival in the GRAALL-2005/R trial.

The event-free survival in 105 patients randomized to receive chemotherapy plus rituximab was 65% after a median of 30 months vs. 52% in the 104 patients who received chemotherapy without rituximab (hazard ratio, 0.66), and the benefit – attributable to a reduction in the cumulative incidence of relapse – persisted on multivariate analysis, Sébastien Maury, MD, of Universite Paris Est in Creteil, France and his colleagues reported ( N Engl J Med. 2016 Sep 15;375[11]:1044-53 ).

The findings were also reported in December 2015 at the annual meeting of the American Society of Hematology.

Study subjects were adults aged 20-59 years who were enrolled between May 2006 and April 2014. No significant increase in toxic effects occurred with the addition of rituximab.

GRAALL-2005/R was funded by the Regional Clinical Research Office, Paris, and by grants from Programme Hospitalier de Recherche Clinique, French Ministry of Health, Institut National du Cancer, and the Swiss State Secretariat for Education, Research, and Innovation. Dr. Maury reported having no disclosures.