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
|
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Published in |
Annals of Hematology, February 2018
|
DOI | 10.1007/s00277-018-3229-5 |
Pubmed ID | |
Authors |
David Martínez-Cuadrón, Blanca Boluda, Pilar Martínez, Juan Bergua, Rebeca Rodríguez-Veiga, Jordi Esteve, Susana Vives, Josefina Serrano, Belen Vidriales, Olga Salamero, Lourdes Cordón, Amparo Sempere, Ana Jiménez-Ubieto, Julio Prieto-Delgado, Marina Díaz-Beyá, Ana Garrido, Celina Benavente, José Antonio Pérez-Simón, Federico Moscardó, Miguel A. Sanz, Pau Montesinos, on behalf of the CETLAM and PETHEMA groups |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Spain | 3 | 43% |
Unknown | 4 | 57% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 5 | 71% |
Practitioners (doctors, other healthcare professionals) | 1 | 14% |
Science communicators (journalists, bloggers, editors) | 1 | 14% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 52 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Ph. D. Student | 7 | 13% |
Other | 6 | 12% |
Student > Master | 6 | 12% |
Researcher | 4 | 8% |
Student > Bachelor | 4 | 8% |
Other | 11 | 21% |
Unknown | 14 | 27% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 17 | 33% |
Biochemistry, Genetics and Molecular Biology | 12 | 23% |
Pharmacology, Toxicology and Pharmaceutical Science | 4 | 8% |
Immunology and Microbiology | 2 | 4% |
Agricultural and Biological Sciences | 1 | 2% |
Other | 0 | 0% |
Unknown | 16 | 31% |