TY - JOUR
T1 - Rituximab-based allogeneic transplant for chronic lymphocytic leukemia with comparison to historical experience
AU - Shadman, Mazyar
AU - Maloney, David G.
AU - Storer, Barry
AU - Sandmaier, Brenda M.
AU - Chauncey, Thomas R.
AU - Smedegaard Andersen, Niels
AU - Niederwieser, Dietger
AU - Shizuru, Judith
AU - Bruno, Benedetto
AU - Pulsipher, Michael A.
AU - Maziarz, Richard T.
AU - Agura, Edward D.
AU - Hari, Parameswaran
AU - Langston, Amelia A.
AU - Maris, Michael B.
AU - McSweeney, Peter A.
AU - Storb, Rainer
AU - Sorror, Mohamed L.
N1 - Funding Information:
Funding Research reported in this paper was supported by the National Cancer Institute of the National Institutes of Health under award number P01 CA078902, P01 CA018029, P30 CA015704, and by the National Heart, Lung, and Blood Institute under K99/R00 HL088021 (MLS). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, which had no involvement in the study design; the collection, analysis and interpretation of data; the writing of the report; nor in the decision to submit the article for publication.
Publisher Copyright:
© 2019, The Author(s), under exclusive licence to Springer Nature Limited.
PY - 2020/1/1
Y1 - 2020/1/1
N2 - Relapse of chronic lymphocytic leukemia (CLL) after allogeneic hematopoietic cell transplantation (HCT) remains a clinical challenge. We studied in a phase II trial whether the addition of peri-transplant rituximab would reduce the relapse risk compared with historical controls (n = 157). Patients (n = 55) received fludarabine and low-dose total body irradiation combined with rituximab on days −3, + 10, + 24, + 36. Relapse rate at 3 years was significantly lower among rituximab-treated patients versus controls (17% versus 31%; P = 0.04). Overall survival (OS), progression-free survival (PFS) and nonrelapse mortality (NRM) were statistically similar: (53% versus 50%; P = 0.8), (44% versus 42%; P = 0.63), and (38% versus 28%; P = 0.2), respectively. In multivariate analysis, rituximab treatment was associated with lower relapse rates both in the overall cohort [hazard ratio (HR): 0.34, P = 0.006] and in patients with high-risk cytogenetics (HR: 0.21, P = 0.0003). Patients with no comorbidities who received rituximab conditioning had an OS rate of 100% and 75% at 1 and 3 years, respectively, with no NRM. Peri-transplant rituximab reduced relapse rates regardless of high-risk cytogenetics. HCT is associated with minimal NRM in patients without comorbidities and is a viable option for patients with high-risk CLL. Clinical trial information: NCT00867529.
AB - Relapse of chronic lymphocytic leukemia (CLL) after allogeneic hematopoietic cell transplantation (HCT) remains a clinical challenge. We studied in a phase II trial whether the addition of peri-transplant rituximab would reduce the relapse risk compared with historical controls (n = 157). Patients (n = 55) received fludarabine and low-dose total body irradiation combined with rituximab on days −3, + 10, + 24, + 36. Relapse rate at 3 years was significantly lower among rituximab-treated patients versus controls (17% versus 31%; P = 0.04). Overall survival (OS), progression-free survival (PFS) and nonrelapse mortality (NRM) were statistically similar: (53% versus 50%; P = 0.8), (44% versus 42%; P = 0.63), and (38% versus 28%; P = 0.2), respectively. In multivariate analysis, rituximab treatment was associated with lower relapse rates both in the overall cohort [hazard ratio (HR): 0.34, P = 0.006] and in patients with high-risk cytogenetics (HR: 0.21, P = 0.0003). Patients with no comorbidities who received rituximab conditioning had an OS rate of 100% and 75% at 1 and 3 years, respectively, with no NRM. Peri-transplant rituximab reduced relapse rates regardless of high-risk cytogenetics. HCT is associated with minimal NRM in patients without comorbidities and is a viable option for patients with high-risk CLL. Clinical trial information: NCT00867529.
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U2 - 10.1038/s41409-019-0660-8
DO - 10.1038/s41409-019-0660-8
M3 - Article
C2 - 31481800
AN - SCOPUS:85072196038
SN - 0268-3369
VL - 55
SP - 172
EP - 181
JO - Bone Marrow Transplantation
JF - Bone Marrow Transplantation
IS - 1
ER -