We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
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.
- Authors
on behalf of the CETLAM and PETHEMA groups; CETLAM and PETHEMA groups; Boluda, Blanca; Rodríguez-Veiga, Rebeca; Moscardó, Federico; Martínez-Cuadrón, David; Cordón, Lourdes; Sempere, Amparo; Montesinos, Pau; Sanz, Miguel A.; Garrido, Ana; Benavente, Celina; Pérez-Simón, José Antonio; Martínez, Pilar; Jiménez-Ubieto, Ana; Bergua, Juan; Prieto-Delgado, Julio; Esteve, Jordi; Díaz-Beyá, Marina; Vives, Susana
- Abstract
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. ClinicalTrials.gov Identifier: NCT01435343.
- Subjects
ACUTE myeloid leukemia; DISEASE relapse; FLUDARABINE; CYTARABINE; ACUTE myeloid leukemia diagnosis; ANTIMETABOLITES; ANTINEOPLASTIC agents; ANTIVIRAL agents; CLINICAL trials; COMPARATIVE studies; GRANULOCYTE-colony stimulating factor; HETEROCYCLIC compounds; RESEARCH methodology; MEDICAL cooperation; RESEARCH; SURVIVAL; EVALUATION research; DISEASE remission; IDARUBICIN
- Publication
Annals of Hematology, 2018, Vol 97, Issue 5, p763
- ISSN
0939-5555
- Publication type
journal article
- DOI
10.1007/s00277-018-3229-5