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Protocols - Hemorio

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- onset of apheresis with CD34 ≥10/µL. Forecast for the onset of the collection D16 (D13-D22).<br />

- ICE:<br />

- Etoposide 100 mg/m 2 D1-D3;<br />

- ifosfamide 5 g/m 2 in a continuous venous infusion at D2;<br />

- mesna 5 g/m 2 in a continuous venous infusion at D2. Dilute with ifosfamide;<br />

- carboplatin at the dose AUC 5 at D2, calculated by the formula 5 x (creatinine clearance + 25). Maximum<br />

dose of 800 mg.<br />

- mabthera 375 mg/m 2 D1 in case of LNH CD20 positive (desirable);<br />

- G-CSF 5 µg/kg every 12 hours from D5;<br />

- onset of apheresis with CD34 ≥10/µL. Forecast for the onset of the collection D14.<br />

- Minimum collection of 2 x 10 6 cells CD34/Kg.<br />

Conditioning and prophylaxis regimen<br />

- Escalated CBV:<br />

- cyclophosphamide 1800 mg/m 2 /day from D-6 to D-3 (total dose of 7200 mg/m 2 );<br />

- Etoposide 400 mg/m 2 every 12 hours from D-6 to D-4 (total dose of 2400 mg/m 2 );<br />

- BCNU 450 mg/m 2 at D-2.<br />

- CBV standard:<br />

- cyclophosphamide 1500 mg/m 2 /day from D-6 to D-3 (total dose of 6000 mg/m 2 );<br />

- Etoposide 200 mg/m 2 every 12 hours from D-6 to D-4 (total dose of 2400 mg/m 2 );<br />

- BCNU 300 mg/m 2 at D-2.<br />

- the choice of regimen with increased or standard doses must be taken by the transplant team;<br />

- mesna 1/6 of the daily dose of cyclophosphamide, starting one hour before each infusion of<br />

cyclophosphamide and every 4 h after the infusion for more five doses (six doses in the total);<br />

- furosemide 10 mg 1 hour, 4 hours and 8 hours after each dose of cyclophosphamide;<br />

- fluconazole 200 mg IV every 12 hours from D-2 until the engraftment;<br />

- acyclovir 250 mg/m 2 IV every 12 hours from D-2 until the engraftment;<br />

- albendazole 400 mg VO for three consecutive days at the hospitalization;<br />

- allopurinol 300 mg VO by day during the conditioning;<br />

- ursodesoxycolic acid 300 mg VO every 12 hours;<br />

- ondansetron 0.15 mg/kg every 6 h in the course of the chemotherapy and until necessary;<br />

- hyperhydration with SG 5% with additives at the volume of 3000 ml/m 2 /day;<br />

- G-CSF 5 µg/kg/day, starting at D+5.<br />

Complimentary radiotherapy: The pre-transplant radiotherapy must be avoided because it increases the<br />

risk of pneumonitis. The radiotherapy located after the autologous transplantation must be evaluated at<br />

the subjects with pre-transplant “bulky disease” or persistence of the located disease after the transplant.<br />

Usage of mabthera in LNH CD20 positive: It is desirable the addition of mabthera to the rescue /<br />

mobilization chemotherapy protocol in subjects with LNH CD20 positive (R-ESHAP or R-ICE). The<br />

maintenance with mabthera monthly for up to 6 months is also desirable (the maintenance length is not<br />

totally established yet).<br />

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