Plerixafor combined with standard regimens for hematopoietic
stem cell mobilization in pediatric patients with solid tumors
eligible for autologous transplants: two-arm phase I/II study
(MOZAIC)

J 2020

Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC)

MORLAND, B., Tomáš KEPÁK, S. DALLORSO, J. SEVILLA, D. MURPHY et. al.

Základní údaje

Originální název

Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC)

Autoři

MORLAND, B. (826 Velká Británie a Severní Irsko, garant), Tomáš KEPÁK (203 Česká republika, domácí), S. DALLORSO (380 Itálie), J. SEVILLA (724 Španělsko), D. MURPHY (826 Velká Británie a Severní Irsko), R. LUKSCH (380 Itálie), I. YANIV (376 Izrael), P. BADER (276 Německo), J. ROSSLER (756 Švýcarsko), G. BISOGNO (380 Itálie), B. MAECKER-KOLHOFF (276 Německo), P. T. LANG (276 Německo), C. M. ZWAAN (528 Nizozemské království), D. SUMERAUER (203 Česká republika), G. KRIVAN (348 Maďarsko), J. BERNARD (840 Spojené státy), Q. Y. LIU (840 Spojené státy), E. DOYLE (840 Spojené státy) a F. LOCATELLI (380 Itálie)

Vydání

Bone Marrow Transplantation, London, Nature Publishing Group, 2020, 0268-3369

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 5.483

Kód RIV

RIV/00216224:14110/20:00116161

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1038/s41409-020-0836-2

UT WoS

000517862900001

Klíčová slova anglicky

COLONY-STIMULATING FACTOR; NON-HODGKINS-LYMPHOMA; CHEMOKINE RECEPTOR; PROGENITOR CELLS; CHILDREN; ANTAGONIST; EFFICACY; AMD3100

Štítky

14110321, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 29. 10. 2020 13:28, Mgr. Tereza Miškechová

Anotace

V originále

This study (NCT01288573) investigated plerixafor's safety and efficacy in children with cancer. Stage 1 investigated the dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor + standard mobilization (G-CSF +/- chemotherapy). The stage 2 primary endpoint was successful mobilization (doubling of peripheral blood CD34+ cell count in the 24 h prior to first apheresis) in patients treated with plerixafor + standard mobilization vs. standard mobilization alone. In stage 1, three patients per age group (2-<6, 6-<12, and 12-<18 years) were treated at each dose level (160, 240, and 320 mu g/kg). Based on PK and PD data, the dose proposed for stage 2 was 240 mu g/kg (patients 1-<18 years), in which 45 patients were enrolled (30 plerixafor arm, 15 standard arm). Patient demographics and characteristics were well balanced across treatment arms. More patients in the plerixafor arm (24/30, 80%) met the primary endpoint of successful mobilization than in the standard arm (4/14, 28.6%, p = 0.0019). Adverse events reported as related to study treatment were mild, and no new safety concerns were identified. Plerixafor + standard G-CSF +/- chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.

Citovat

MORLAND, B., Tomáš KEPÁK, S. DALLORSO, J. SEVILLA, D. MURPHY, R. LUKSCH, I. YANIV, P. BADER, J. ROSSLER, G. BISOGNO, B. MAECKER-KOLHOFF, P. T. LANG, C. M. ZWAAN, D. SUMERAUER, G. KRIVAN, J. BERNARD, Q. Y. LIU, E. DOYLE a F. LOCATELLI. Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC). Bone Marrow Transplantation. London: Nature Publishing Group, 2020, roč. 55, č. 9, s. 1744-1753. ISSN 0268-3369. Dostupné z: https://dx.doi.org/10.1038/s41409-020-0836-2.

@article{1673730,
   author = {Morland, B. and Kepák, Tomáš and Dallorso, S. and Sevilla, J. and Murphy, D. and Luksch, R. and Yaniv, I. and Bader, P. and Rossler, J. and Bisogno, G. and MaeckerandKolhoff, B. and Lang, P. T. and Zwaan, C. M. and Sumerauer, D. and Krivan, G. and Bernard, J. and Liu, Q. Y. and Doyle, E. and Locatelli, F.},
   article_location = {London},
   article_number = {9},
   doi = {http://dx.doi.org/10.1038/s41409-020-0836-2},
   keywords = {COLONY-STIMULATING FACTOR; NON-HODGKINS-LYMPHOMA; CHEMOKINE RECEPTOR; PROGENITOR CELLS; CHILDREN; ANTAGONIST; EFFICACY; AMD3100},
   language = {eng},
   issn = {0268-3369},
   journal = {Bone Marrow Transplantation},
   title = {Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC)},
   url = {https://www.nature.com/articles/s41409-020-0836-2},
   volume = {55},
   year = {2020}
}

TY  - JOUR
ID  - 1673730
AU  - Morland, B. - Kepák, Tomáš - Dallorso, S. - Sevilla, J. - Murphy, D. - Luksch, R. - Yaniv, I. - Bader, P. - Rossler, J. - Bisogno, G. - Maecker-Kolhoff, B. - Lang, P. T. - Zwaan, C. M. - Sumerauer, D. - Krivan, G. - Bernard, J. - Liu, Q. Y. - Doyle, E. - Locatelli, F.
PY  - 2020
TI  - Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC)
JF  - Bone Marrow Transplantation
VL  - 55
IS  - 9
SP  - 1744-1753
EP  - 1744-1753
PB  - Nature Publishing Group
SN  - 02683369
KW  - COLONY-STIMULATING FACTOR
KW  - NON-HODGKINS-LYMPHOMA
KW  - CHEMOKINE RECEPTOR
KW  - PROGENITOR CELLS
KW  - CHILDREN
KW  - ANTAGONIST
KW  - EFFICACY
KW  - AMD3100
UR  - https://www.nature.com/articles/s41409-020-0836-2
L2  - https://www.nature.com/articles/s41409-020-0836-2
N2  - This study (NCT01288573) investigated plerixafor's safety and efficacy in children with cancer. Stage 1 investigated the dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor + standard mobilization (G-CSF +/- chemotherapy). The stage 2 primary endpoint was successful mobilization (doubling of peripheral blood CD34+ cell count in the 24 h prior to first apheresis) in patients treated with plerixafor + standard mobilization vs. standard mobilization alone. In stage 1, three patients per age group (2-<6, 6-<12, and 12-<18 years) were treated at each dose level (160, 240, and 320 mu g/kg). Based on PK and PD data, the dose proposed for stage 2 was 240 mu g/kg (patients 1-<18 years), in which 45 patients were enrolled (30 plerixafor arm, 15 standard arm). Patient demographics and characteristics were well balanced across treatment arms. More patients in the plerixafor arm (24/30, 80%) met the primary endpoint of successful mobilization than in the standard arm (4/14, 28.6%, p = 0.0019). Adverse events reported as related to study treatment were mild, and no new safety concerns were identified. Plerixafor + standard G-CSF +/- chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.
ER  -

MORLAND, B., Tomáš KEPÁK, S. DALLORSO, J. SEVILLA, D. MURPHY, R. LUKSCH, I. YANIV, P. BADER, J. ROSSLER, G. BISOGNO, B. MAECKER-KOLHOFF, P. T. LANG, C. M. ZWAAN, D. SUMERAUER, G. KRIVAN, J. BERNARD, Q. Y. LIU, E. DOYLE a F. LOCATELLI. Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC). \textit{Bone Marrow Transplantation}. London: Nature Publishing Group, 2020, roč.~55, č.~9, s.~1744-1753. ISSN~0268-3369. Dostupné z: https://dx.doi.org/10.1038/s41409-020-0836-2.

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