RT Journal Article
T1 A phase I-II study of plerixafor in combination with fludarabine, idarubicin, cytarabine, and G-CSF (PLERIFLAG regimen) for the treatment of patients with the first early-relapsed or refractory acute myeloid leukemia.
A1 Martinez-Cuadron, David
A1 Boluda, Blanca
A1 Martinez, Pilar
A1 Bergua, Juan
A1 Rodriguez-Veiga, Rebeca
A1 Esteve, Jordi
A1 Vives, Susana
A1 Serrano, Josefina
A1 Vidriales, Belen
A1 Salamero, Olga
A1 Cordon, Lourdes
A1 Sempere, Amparo
A1 Jimenez-Ubieto, Ana
A1 Prieto-Delgado, Julio
A1 Diaz-Beya, Marina
A1 Garrido, Ana
A1 Benavente, Celina
A1 Perez-Simon, Jose Antonio
A1 Moscardo, Federico
A1 Sanz, Miguel A
A1 Montesinos, Pau
K1 Idarubicin
K1 Disease-Free Survival
K1 Granulocyte Colony-Stimulating Factor
K1 Hematopoietic Stem Cell Mobilization
AB Clinical outcomes of patients with acute myeloid leukemia (AML) showing the first primary refractory or early-relapsed disease remain very poor. The Programa Español de Tratamientos en Hematología (PETHEMA) group designed a phase I–II trial using FLAG-Ida (fludarabine, idarubicin, cytarabine, and G-CSF) plus high-dose intravenous plerixafor, a molecule inducing mobilization of blasts through the SDF-1α-CXCR4 axis blockade and potentially leading to chemosensitization of the leukemic cells. We aimed to establish a recommended phase 2 dose (RP2D) of plerixafor plus FLAG-Ida, as well as the efficacy and safety of this combination for early-relapsed (first complete remission (CR/CRi) < 12 months) or primary refractory AML. Between 2012 and 2015, 57 patients were enrolled, and 41 received the RP2D (median age 52 years [range, 18–64]). Among these patients, 20 (49%) achieved CR/CRi, and 3 (7%) died during induction. CR/CRi rate was 50% (13/26) among primary refractory and 47% (7/15) among early relapse. Overall, 25 patients (61%) were allografted. Median overall and disease-free survivals were 9.9 and 13 months, respectively. In summary, the combination of plerixafor plus FLAG-Ida resulted in a relatively high CR/CRi rate in adult patients with primary refractory or early relapsed AML, with an acceptable toxicity profile and induction mortality rate, bridging the majority of patients to allogeneic stem cell transplantation
PB Springer
YR 2018
FD 2018
LK http://hdl.handle.net/10668/12172
UL http://hdl.handle.net/10668/12172
LA en
NO Martínez-Cuadrón D, Boluda B, Martínez P, Bergua J, Rodríguez-Veiga R, Esteve J, et al. A phase I-II study of plerixafor in combination with fludarabine, idarubicin, cytarabine, and G-CSF (PLERIFLAG regimen) for the treatment of patients with the first early-relapsed or refractory acute myeloid leukemia. Ann Hematol. 2018 May;97(5):763-772
DS RISalud
RD Jul 31, 2025