Hematopoietic progenitor cells‐apheresis (HPC‐A) collection is now a routine procedure for autologous hematopoietic stem cell transplantation. Here we present our 25 years' experience of HPC‐A ...collection in children weighing 8 kg or less, with a focus on the evolution of our standard operating procedures, and the safety limits for these young patients, in the Pediatric Apheresis Unit of Clermont‐Ferrand University Hospital (France). Fifteen children weighing 8 kg or less underwent 26 HPC‐A collections over 25 years. Median CD34+ cell yield by leukapheresis was 4.4 106/kg. No procedure‐related complications were encountered during or after the collection. No patient had profound thrombocytopenia or anemia that needed post‐collection transfusions. Our experience in pediatric oncology patients who underwent HPC‐A collections shows that this procedure can be performed even in the smallest of children with no increase in toxicity provided all precautions are taken to ensure that the procedure is carried out under the ideal conditions.
BACKGROUND: Extracorporeal photochemotherapy (ECP) gives positive results in the management of graft‐versus‐host disease (GVHD), but in children, specific difficulties can outweigh this benefit. ...These difficulties must be taken into consideration when establishing a standardized reproducible procedure for implementation under a quality management plan.
STUDY DESIGN AND METHODS: Twenty‐seven children underwent ECP for severe acute GVHD (aGVHD) or chronic GVHD (cGVHD) after allogeneic marrow transplantation. Data were collected prospectively, with particular emphasis placed on technical, biologic, immunologic, clinical, and long‐term follow‐up issues.
RESULTS: The 27 children underwent a total of 750 sessions. Mononuclear cells were collected on a commercially available apheresis system (COBE Spectra, Gambro BCT). Overall survival was 73 percent, and ECP led to significant improvement in 21 of the 27 patients (11 with complete response and 10 with partial response, i.e., >50% of organ involvement). Tolerance was good overall, the main limiting factors being vascular access and the psychological impact of repeated apheresis procedures. Children weighing less than 25 kg were not more susceptible to side effects.
CONCLUSION: A specifically pediatric‐dedicated and ‐experienced team faces only limited difficulties when treating children with GVHD by ECP. Overall, ECP is efficient and well tolerated. Our experience was therefore pooled together with available pediatric data to establish clinical practice guidelines. These guidelines consider ECP as a first‐line therapy in Grade IV aGVHD (in association with conventional pharmacologic approaches) and limited cGVHD and as a second‐line therapy in steroid‐resistant Grades II to III aGVHD and extensive cGVHD.
We describe 16 leukapheresis (LK) procedures performed in 7 children with different types of leukemia and hyperleukocytosis. We also provide an analysis of previously published experiences of ...pediatric LK. Median age and body weight of patients were 12.3 years (range, 0.2 to 16.7 y) and 49 kg (range, 5 to 61 kg). Immediate pre-first-LK median white blood cell count was 478×10/L (108×10/L to 988×10/L). All cytoreduction were performed on Cobe Spectra cell separator. Sixty-eight percent of procedures were performed with peripheral veins. Extracorporeal line had been primed with red blood cell for 31% of LK. The median decrease in white blood cell count after each LK was 33% (0% to 69%), and overall decrease after completion of LK procedures was 62% (11% to 94%). Only minor clinical adverse events and no metabolic complication were attributable to LK. No more clinical symptom of hyperleukocytosis was observed after completion of LK procedures. Our findings are consistent with reported results in other pediatric series: LK is a well-tolerated procedure that can be safely performed with an experienced pediatric team even on the smallest children.
Extracorporeal photochemotherapy: past-it or promising? Merlin, Etienne; Kanold, Justyna; Deméocq, François
Expert opinion on biological therapy,
2012-September, 9/1/2012, 2012-Sep, 2012-09-00, Letnik:
12, Številka:
9
Journal Article
Recenzirano
Odprti dostop
Extracorporeal photochemotherapy has been used for almost three decades for the treatment of several T-cell-mediated diseases, and its efficacy has been proven in few well-designed controlled ...randomized trials. However, to date, there are no reliable data on a hypothetic dose-effect, optimal rhythm of administration, drug interactions, or the "pharmacokinetics" and "pharmacodynamics" of this cell therapy. In particular, it is not clear whether ECP gains to be used in combination with immunosuppressive or immunomodulative drugs. In the future, clinical trials may address these issues in order to clarify the most beneficial use of a cell therapy which absence of toxicity is uniformly recognized.
BACKGROUND: Using autologous cryopreserved mononuclear cells (MNCs) for extracorporeal photochemotherapy (ECP) offers several advantages, such as treating patients from geographically distant care ...centers or maintaining ECP schedule while dramatically reducing number of apheresis sessions. We previously reported that cryopreserved cells retain their immunomodulatory properties when exposed to UVA and psoralen. To date, there are no clinical data on the use of cryopreserved MNCs for ECP (“cryo‐ECP”).
CASE REPORTS: Three patients were treated by cryo‐ECP for refractory dermatomyositis, juvenile localized scleroderma, and acute graft‐versus‐host disease. For the first two patients, cryo‐ECP aimed to reduce the number of apheresis sessions. Each cell product was split into three equal fractions: one was infused, and the other two were frozen for later infusion. The third patient was referred to our center from a hospital 700 km away. Fifteen apheresis procedures were performed during his stay: 12 were immediately treated and infused while three were cryopreserved. After discharge, the three cryopreserved bags were thawed, ECP‐treated, and then sent back to the patient.
CONCLUSION: In all three patients, cryo‐ECP was safe and feasible. These cases illustrate promising clinical applications of the technique, opening perspectives for making ECP much more acceptable to patients while extending its indications.
Abstract Background The rapid kinetics of hematopoietic stem cells induced by Plerixafor (Mozobil®, Genzyme) should be of particular interest in children. We therefore conducted a prospective trial ...to determine whether a one-day mobilization by plerixafor alone was efficient enough in children with cancer. Methods Children with solid malignancies were consecutively recruited for this phase-IIA, Bayesian single-center prospective study. Mobilization consisted in one subcutaneous injection of 240 μg plerixafor/kg body weight at 8 a.m. (h0). Collection by apheresis began at h5 provided that CD34+ count exceeded 10 × 106 /L. Our main evaluation criterion was percent of children in which at least 5 × 106 CD34+/kg could be collected during the first apheresis. Results No patients fulfilled the success criterion, and so a stopping criterion was met after 5 patients. All patients reached the threshold value of 10 × 106 CD34+ cells/L post-injection and so all were eligible for apheresis. Peak CD34+ cell values were ranged from 11 to 44 × 106 /L and were reached in 4 h to 6 h. No side-effects were observed. Median number of CD34+ cells collected per patient BW was 1.62 × 106 0.47−3.5. In 3 of the 5 patients, collection was >1.5 × 106 CD34+/kg BW. Conclusion In children, a ‘one-day’ mobilization regimen consisting of one injection of 240 μg/kg plerixafor alone in hematological steady state provides a faster and shorter mobilization than in adults. This strategy may be an attractive option for completing an insufficient graft. More studies are warranted to optimize the use of plerixafor in children.
Background
Apheresis is a major challenge in peripheral stem cell collection from low‐weight children with cancer. Comparisons between the new apheresis device Optia (TerumoBCT) and the earlier COBE ...Spectra (CaridianBCT) have been performed in adults but not in low‐weight children. The objective was to compare the performance of these two devices in small children.
Study Design and Methods
In this retrospective study, all patients were reviewed weighing less than 15 kg undergoing stem cell collection using the Optia device between April 2011 and April 2012. They were paired on weight in a 3:1 ratio with patients whose cells had been collected with the COBE Spectra since 2006.
Results
Six patients were treated with the Optia and were matched with 18 patients treated with the Spectra. No side effects occurred. Collection efficiency (CE) was similar between the two groups (50% vs. 47%), but CD34 cell blood clearance was lower with the Optia (0.4 mL/min/kg vs. 0.6 mL/min/kg, p < 0.01). Platelet (PLT) loss and hemoglobin (Hb) loss were significantly reduced with the Optia (respectively, 32% vs. 54%, p < 0.01; and 1.4 g/dL vs. 2.9 g/dL, p < 0.01). Apheresis duration was increased with the Optia (159 min vs. 134 min, p < 0.05). The cell product harvested with the Optia had a lower volume and lower hematocrit, but similar white blood cell and PLT content.
Conclusion
Compared with the Spectra, the Optia allows similar CE with a reduced PLT and Hb loss but with a longer duration.
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