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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)

B. Morland, T. Kepak, S. Dallorso, J. Sevilla, D. Murphy, R. Luksch, I. Yaniv, P. Bader, J. Rößler, G. Bisogno, B. Maecker-Kolhoff, P. Lang, CM. Zwaan, D. Sumerauer, G. Kriván, J. Bernard, Q. Liu, E. Doyle, F. Locatelli

. 2020 ; 55 (9) : 1744-1753. [pub] 20200303

Jazyk angličtina Země Velká Británie

Typ dokumentu klinické zkoušky, fáze I, klinické zkoušky, fáze II, časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc21020159
E-zdroje Online Plný text

NLK Free Medical Journals od 1997 do Před 1 rokem
Freely Accessible Science Journals od 1997 do Před 1 rokem
ProQuest Central od 2000-01-01 do Před 1 rokem
Open Access Digital Library od 1997-01-01
Health & Medicine (ProQuest) od 2000-01-01 do Před 1 rokem

Odkazy

PubMed 32127657
DOI 10.1038/s41409-020-0836-2
Knihovny.cz E-zdroje

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 µg/kg). Based on PK and PD data, the dose proposed for stage 2 was 240 µg/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.

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