Study Design

ALFA-0701 supports the addition of MYLOTARG to standard of care in adults with newly diagnosed CD33-positive AML1
The ALFA-0701 trial was a Phase 3, multicenter, randomized, open-label study of 271 patients aged 50 to 70 years with newly diagnosed de novo AML1,2
  • Patients who did not achieve a response after first induction could receive a second induction with daunorubicin and cytarabine alone
  • Patients who responded received 2 courses of consolidation therapy with daunorubicin and cytarabine with or without MYLOTARG on Day 1, according to their initial randomization
  • Patients who experienced remission were also eligible for allogeneic transplantation. In the study, an interval of at least 2 months between the last dose of MYLOTARG and transplantation was recommended
AraC=cytarabine; CR=complete remission; CRp=CR with incomplete platelet recovery; D=day; DNR=daunorubicin; EFS=event-free survival; RFS=relapse-free survival; OS=overall survival.
AML=acute myeloid leukemia; chemo=daunorubicin + cytarabine; CHV=Centre Hospitalier de Versailles, Le Chesnay, France; ECOG PS=Eastern Cooperative Oncology Group performance status; ELN=European LeukemiaNet.
*Based on 2010 ELN risk stratification guidelines, in which “Favorable/Intermediate” is comprised of “Favorable,” “Intermediate I,” and “Intermediate II.”
As classified by CHV.
REFERENCES
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.
2. Data on file. Pfizer Inc, New York, NY.