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@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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