We enrolled 54 patients. 12 patients were enrolled in the first cohort using CLAG-M and 3-Gray TBI. 24 patients were enrolled in the second cohort using CLAG-M and 4-Gray TBI. And currently we have 18 patients who received FLAG-Ida followed by TBI in the third cohort. The main finding of the study is that patients tolerated the therapy quite well with a non-relapse mortality at one year of 12%. The other main finding of the study is that the disease-free survival at one year for these high-risk patients was 50%...
We enrolled 54 patients. 12 patients were enrolled in the first cohort using CLAG-M and 3-Gray TBI. 24 patients were enrolled in the second cohort using CLAG-M and 4-Gray TBI. And currently we have 18 patients who received FLAG-Ida followed by TBI in the third cohort. The main finding of the study is that patients tolerated the therapy quite well with a non-relapse mortality at one year of 12%. The other main finding of the study is that the disease-free survival at one year for these high-risk patients was 50%. There were differences between cohorts with higher survival rate for patients receiving 4-Gray TBI along with either CLAG-M or FLAG-Ida, while we did see worse outcomes in patients receiving 3-Gray TBI along with CLAG-M. There are many factors that can explain that. The most important one to consider is that all patients in the first cohort received cryopreserved products due to the pandemic, and while fewer patients received cryopreserved products in the second cohort and none in the third cohort. The other main finding of the study is that this sequential conditioning was tolerated well by patients and potentially can be extended to other post-transplant therapies to reduce the relapse rate. Relapse rate, as a matter of fact, remains the main problem of this study with about 39% of the patients relapsing at one year. So addressing relapse will be the next step to improve the outcomes of these studies.
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