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• W2005835949 abstract "We previously reported that rituximab was associated with a reduced incidence of acute graft versus host disease (GVHD) when incorporated into a standard transplant preparative regimen for ALL. To confirm our findings, we conducted a randomized, prospective study. Methods: Adult ALL pts received a standard myeloablative conditioning regimen of total body irradiation (TBI, 12 Gy in four daily fractions) followed by etoposide 60 mg/kg x 1 dose with allogeneic HSCT. Rituximab was administered at 375 mg/m2 on days -7, -1, +7 and +14 following stem cell infusion in pts randomized to receive the drug. GVHD prophylaxis consisted of tacrolimus and mini-dose methotrexate for all pts, and anti-thymocyte-globulin was added to matched unrelated pts. Palifermin to reduce the incidence of mucositis was administered to all pts. The first 20 pts were randomized equally to the possibility of receiving rituximab, with subsequent randomization based on a Bayesian adaptive algorithm. Results: Twenty-one pts have been entered onto study. Patient characteristics and treatment outcomes are detailed in Table 1. Of note, there were greater numbers of pts with disease beyond CR1 in the rituximab group. There was no significant difference between the 2 treatment groups with respect to the incidence of acute GVHD; 3 pts in the rituximab group developed chronic extensive GVHD. Seven of 10 (70%) pts on the rituximab treatment arm have died with a median time to death of 6.9 months: relapse n = 4, infection n = 2, organ failure n = 1; no pts on the standard treatment arm have died with a median follow-up of 14 months (range 3–32 months). Overall survival for the rituximab group was significantly worse at 30% versus 100% for the standard treatment arm, p = 0.005. Four of 10 (40%) pts on the rituximab treatment arm have had progressive disease, and all 4 of these pts died. Only 1 of 11 (9%) pts on the standard treatment arm had progressive disease at 14.5 months after HSCT and remains alive at 17.6 months after HSCT. In conclusion, our results demonstrate that the addition of rituximab to the standard etoposide and TBI conditioning regimen for allogeneic HSCT in ALL does not impact GVHD. Furthermore, rituximab appears to negatively impact survival, with increased risk of disease relapse. However, the small sample size and greater numbers of pts with advanced disease in the rituximab arm limit these conclusions.Tabled 1Table 1. Patient Characteristics and Treatment ResultsEtoposide/TBIEtoposide/TBI/RituximabP-valueNo. ptsNo. ptsTotal Treated1110Median Recipient Age in Years (range)33 (20-47)32 (19-52)0.382Gender (%):0.999Female3 (27)3 (30)Male8 (73)7 (70)Diagnosis Status (%)0.158CR17 (64)3 (30)CR24 (36)3 (30)Beyond CR20 (0)1 (10)Relapse0 (0)3 (30)Histology (%):0.035T-cell0 (0)4 (40)B-cell11 (100)6 (60)Ph+ (%)0.311No7 (64)9 (90)Yes4 (36)1 (10)Donor Type (%)0.387Matched related6 (55)3 (30)Matched unrelated5 (45)7 (70)Stem Cell Source (%)∗0.008Bone marrow3 (27)9 (90)Peripheral blood8 (73)1 (10)Acute GVHD (%)0.999Grades II-IV3 (27)9 (90)Grades III-IV00Chronic Extensive GVHD (%)03 (33)0.090Overall Survival100%30%0.005Progression-Free Survival90%60%0.009 Open table in a new tab" @default.
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• W2005835949 date "2009-02-01" @default.
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• W2005835949 title "Inferior Outcome With Addition Of Rituximab For Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) In Acute Lymphoblastic Leukemia (ALL)" @default.
• W2005835949 doi "https://doi.org/10.1016/j.bbmt.2008.12.361" @default.
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