RESUMEN
We conducted a prospective clinical trial to investigate the safety and efficacy of plerixafor (P) in allogeneic peripheral blood stem cells (PBSC) donors with poor mobilization response to standard-dose granulocyte colony-stimulating factor (G-CSF), defined by <2 × 106 CD34 + cells/kg recipient body-weight (CD34+/kg RBW) after 1st apheresis. A single dose of 240 µg/kg P was injected subcutaneously at 10 p.m. on the day of the 1st apheresis. Thirty-seven allogeneic PBSC donors underwent study treatment. The median CD34+ count in peripheral blood was 15/µl on Day 1 after G-CSF alone, versus 44/µl on Day 2 after G-CSF plus P (p < 0.001). The median yield of CD34+ cells was 1.1 × 108 on Day 1 and 2.8 × 108 on Day 2. In contrast to a median yield of only 1.31 × 106 CD CD34+/kg RBW on Day 1, triggering study inclusion, a median of 3.74 × 106 CD CD34+/kg RBW were collected with G-CSF plus P on Day 2. Of 37 donors, 21 reached the target cell count of >4.5 × 106 CD34+/kg RBW (57%, 95%CI 40-73%). No donor experienced a severe adverse event requiring treatment. In conclusion, P might be considered on a case-by-case basis for healthy allogeneic donors with very poor stem cell mobilization success after G-CSF.
Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Compuestos Heterocíclicos , Células Madre de Sangre Periférica , Antígenos CD34 , Bencilaminas , Ciclamas , Factor Estimulante de Colonias de Granulocitos , Movilización de Célula Madre Hematopoyética , Humanos , Estudios Prospectivos , Terapia RecuperativaRESUMEN
BACKGROUND: Peripheral blood stem cell (PBSC) collection is accepted as a routine procedure in related and unrelated healthy donors worldwide. Venous access can be accomplished by peripheral veins or a central venous catheter (CVC). STUDY DESING AND METHODS: We compared efficacy and tolerability of 40 PBSC collections via CVC with 6267 PBSC collections via peripheral veins in healthy allogeneic donors. Results of the leukapheresis procedures and side effects in the donors were evaluated. RESULTS: The median CD34+ cell counts on Day 5 and the results of the stem cell collection were not significantly different between the two groups of allogeneic donors. Pain or problems at the site of puncture or catheter insertion occurred in 58.6% of the donors with a CVC versus 37.8% of the donors with peripheral venous access (p = 0.03). The incidence and severity of paresthesia during the leukapheresis was not significantly different in both groups of donors (p = 0.09). During follow-up no major adverse events related to CVC were reported. CONCLUSION: Central femoral lines proved to be safe and tolerable in healthy allogeneic donors but peripheral venous access should be preferred, whenever possible.
Asunto(s)
Donantes de Sangre , Cateterismo Venoso Central/métodos , Cateterismo Periférico/métodos , Células Madre Hematopoyéticas/citología , Leucaféresis/métodos , Adulto , Anciano , Cateterismo Venoso Central/efectos adversos , Cateterismo Venoso Central/estadística & datos numéricos , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Movilización de Célula Madre Hematopoyética/métodos , Trasplante de Células Madre Hematopoyéticas , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Parestesia/epidemiología , Parestesia/prevención & control , Trasplante Homólogo , Adulto JovenRESUMEN
BACKGROUND: A single injection of pegfilgrastim has been shown to be equivalent to daily filgrastim in enhancing neutrophil recovery after chemotherapy, whereas the experiences with pegfilgrastim in mobilization of peripheral blood progenitor cells (PBPCs) are limited. STUDY DESIGN AND METHODS: Forty unselected patients with lymphoma or multiple myeloma were treated with different chemotherapy regimens followed by 6 mg of pegfilgrastim for mobilization of autologous PBPCs. Patients with an inadequate mobilization (blood CD34+ cells Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación
, Factor Estimulante de Colonias de Granulocitos/administración & dosificación
, Movilización de Célula Madre Hematopoyética
, Linfoma/terapia
, Mieloma Múltiple/terapia
, Trasplante de Células Madre de Sangre Periférica
, Adulto
, Anciano
, Carmustina/administración & dosificación
, Citarabina/administración & dosificación
, Dexametasona/administración & dosificación
, Etopósido/administración & dosificación
, Femenino
, Filgrastim
, Humanos
, Masculino
, Melfalán/administración & dosificación
, Persona de Mediana Edad
, Polietilenglicoles
, Proteínas Recombinantes
, Inducción de Remisión
, Trasplante Autólogo
, Resultado del Tratamiento
RESUMEN
BACKGROUND AND OBJECTIVES: Short-term treatment with granulocyte colony-stimulating factor (G-CSF) has been established as the standard regimen for mobilizing allogeneic peripheral blood progenitor cells (PBPC) from healthy donors. The pegylated form of filgrastim (pegfilgrastim) has a longer elimination half-life because of decreased serum clearance and might be a convenient alternative for stem cell mobilization. DESIGN AND METHODS: Twenty-five family (n=15) or unrelated (n=10) healthy donors received a single-dose of 12 mg pegfilgrastim for mobilization of allogeneic PBPC. Donors with inadequate mobilization (blood CD34+ cells Asunto(s)
Factor Estimulante de Colonias de Granulocitos/farmacología
, Movilización de Célula Madre Hematopoyética
, Donadores Vivos
, Adulto
, Anciano
, Antígenos CD34/análisis
, Evaluación de Medicamentos
, Femenino
, Filgrastim
, Citometría de Flujo
, Enfermedad Injerto contra Huésped/etiología
, Enfermedad Injerto contra Huésped/prevención & control
, Factor Estimulante de Colonias de Granulocitos/efectos adversos
, Movilización de Célula Madre Hematopoyética/efectos adversos
, Humanos
, Interleucina-10/metabolismo
, Leucaféresis
, Recuento de Leucocitos
, Masculino
, Persona de Mediana Edad
, Monocitos/efectos de los fármacos
, Monocitos/metabolismo
, Dolor/inducido químicamente
, Dimensión del Dolor
, Trasplante de Células Madre de Sangre Periférica/efectos adversos
, Polietilenglicoles
, Proteínas Recombinantes
, Estudios Retrospectivos
, Esplenomegalia/inducido químicamente
, Linfocitos T Reguladores/metabolismo
, Trasplante Homólogo/efectos adversos