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Secondary central nervous system (CNS) lymphoma is a rare but potentially fatal event in patients with diffuse large B-cell lymphoma.
study aims to assess the activity and safety of CNS-directed immunotherapy enhanced by autologic hematopoietic stem cell transplantation (HSCT) in patients with secondary CNS lymphoma.
the international one-arm phase 2 trial at 24 hospitals in Italy, the UK, the Netherlands and Switzerland.
adult patients (18-70 years old) who were diagnosed with diffuse large B-cell lymphoma and CNS-affected initial diagnosis or recurrence, ECOG performance status≤3 points, were treated with MATRix for three courses (18-70 years old) Lytoxi monoantigens and methotrexates, glycosides and thiopentals instead of bar), and then three courses of RIC (Lytoxi monoantigens, etoposides, isopramides and carbasins and carbases and HSCT).
end of the year is a year of progress-free survival.
secondary endpoints include the total response rate and full response rate before the body HSCT, the response duration, the total survival rate, and safety.
79 patients were selected between March 30, 2015 and August 3, 2018.
75 patients can be assessed.
319 (71 per cent) of the 450 planned treatments.
, the main endpoint was reached one year after joining the group, with 42 patients with no progression (no progression survival rate of 58 per cent; 95 per cent CI 55-61).
treatment with MATRix-RICE, 49 patients (65 percent; 95 percent CI 54-76) received objective remission, of which 29 (39 percent) were fully relieved.
37 patients who received remission received self-effect HSCT.
at the end of the programme, 46 patients (61 per cent; 95 per cent CI 51-71) received objective remission with a medium duration of 26 months (IQR 16-37).
29 months of medium follow-up (IQR 20-40), 35 patients showed no progression, 33 survived, and the two-year total survival rate was 46% (95% CI 39-53).
level 3-4 toxicity of adverse reactions is blood toxicity: neutral granulocyte reduction (61%), plateplate reduction (60%), anemia (35%).
79 serious adverse events occurred in 42 (56%) patients, of which 4 (5%) died from Terrain-negative sepsis (treatment-related mortality rate of 5%; 95% CI 0.07-9.93).
, the MATRix-RICE programme combined with the self-contained HSCT for the treatment of patients with very poor prognosis was significant and the toxicity intensity was acceptable.