TY  - JOUR
A1  - Zugmaier, G.
A1  - Topp, M. S.
A1  - Alekar, S.
A1  - Viardot, A.
A1  - Horst, H.-A.
A1  - Neumann, S.
A1  - Stelljes, M.
A1  - Bargou, R. C.
A1  - Goebeler, M.
A1  - Wessiepe, D.
A1  - Degenhard, E.
A1  - Goekbuget, N.
A1  - Klinger, M.
T1  - Long-term follow-up of serum immunoglobulin levels in blinatumomab-treated patients with minimal residual disease-positive B-precursor acute lymphoblastic leukemia
JF  - Blood Cancer Journal
N2  - No abstract available.
KW  - stem-cell transplantation
KW  - free survival
KW  - engaging aantibody
KW  - Rituximab
KW  - lymphoma
KW  - hypogammaglobulinemia
KW  - lineage
Y1  - 2014
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-115433
SN  - 2044-5385
VL  - 4
IS  - e244
ER  - 
TY  - JOUR
A1  - Gökbuget, N.
A1  - Kelsh, M.
A1  - Chia, V.
A1  - Advani, A.
A1  - Bassan, R.
A1  - Dombret, H.
A1  - Doubek, M.
A1  - Fielding, A. K.
A1  - Giebel, S.
A1  - Haddad, V.
A1  - Hoelzer, D.
A1  - Holland, C.
A1  - Ifrah, N.
A1  - Katz, A.
A1  - Maniar, T.
A1  - Martinelli, G.
A1  - Morgades, M.
A1  - O'Brien, S.
A1  - Ribera, J.-M.
A1  - Rowe, J. M.
A1  - Stein, A.
A1  - Topp, M.
A1  - Wadleigh, M.
A1  - Kantarjian, H.
T1  - Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
JF  - Blood Cancer Journal
N2  - We compared outcomes from a single-arm study of blinatumomab in adult patients with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia (R/R ALL) with a historical data set from Europe and the United States. Estimates of complete remission (CR) and overall survival (OS) were weighted by the frequency distribution of prognostic factors in the blinatumomab trial. Outcomes were also compared between the trial and historical data using propensity score methods. The historical cohort included 694 patients with CR data and 1112 patients with OS data compared with 189 patients with CR and survival data in the blinatumomab trial. The weighted analysis revealed a CR rate of 24% (95% CI: 20–27%) and a median OS of 3.3 months (95% CI: 2.8–3.6) in the historical cohort compared with a CR/CRh rate of 43% (95% CI: 36–50%) and a median OS of 6.1 months (95% CI: 4.2–7.5) in the blinatumomab trial. Propensity score analysis estimated increased odds of CR/CRh (OR=2.68, 95% CI: 1.67–4.31) and improved OS (HR=0.536, 95% CI: 0.394–0.730) with blinatumomab. The analysis demonstrates the application of different study designs and statistical methods to compare novel therapies for R/R ALL with historical data.
KW  - Acute lymphocytic leukaemia
KW  - Drug development
Y1  - 2016
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-164495
VL  - 6
ER  - 
TY  - JOUR
A1  - Topp, Max S.
A1  - van Meerten, Tom
A1  - Houot, Roch
A1  - Minnema, Monique C.
A1  - Bouabdallah, Krimo
A1  - Lugtenburg, Pieternella J.
A1  - Thieblemont, Catherine
A1  - Wermke, Martin
A1  - Song, Kevin W.
A1  - Avivi, Irit
A1  - Kuruvilla, John
A1  - Dührsen, Ulrich
A1  - Zheng, Yan
A1  - Vardhanabhuti, Saran
A1  - Dong, Jinghui
A1  - Bot, Adrian
A1  - Rossi, John M.
A1  - Plaks, Vicki
A1  - Sherman, Marika
A1  - Kim, Jenny J.
A1  - Kerber, Anne
A1  - Kersten, Marie José
T1  - Earlier corticosteroid use for adverse event management in patients receiving axicabtagene ciloleucel for large B-cell lymphoma
JF  - British Journal of Haematology
N2  - Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for relapsed or refractory large B-cell lymphoma (R/R LBCL). To reduce axi-cel–related toxicity, several exploratory safety management cohorts were added to ZUMA-1 (NCT02348216), the pivotal phase 1/2 study of axi-cel in refractory LBCL. Cohort 4 evaluated the rates and severity of cytokine release syndrome (CRS) and neurologic events (NEs) with earlier corticosteroid and tocilizumab use. Primary endpoints were incidence and severity of CRS and NEs. Patients received 2 × 106 anti-CD19 CAR T cells/kg after conditioning chemotherapy. Forty-one patients received axi-cel. Incidences of any-grade CRS and NEs were 93% and 61%, respectively (grade ≥ 3, 2% and 17%). There was no grade 4 or 5 CRS or NE. Despite earlier dosing, the cumulative cortisone-equivalent corticosteroid dose in patients requiring corticosteroid therapy was lower than that reported in the pivotal ZUMA-1 cohorts. With a median follow-up of 14·8 months, objective and complete response rates were 73% and 51%, respectively, and 51% of treated patients were in ongoing response. Earlier and measured use of corticosteroids and/or tocilizumab has the potential to reduce the incidence of grade ≥ 3 CRS and NEs in patients with R/R LBCL receiving axi-cel.
KW  - toxicity
KW  - large B-cell lymphoma
KW  - axi-cel
KW  - CAR T
KW  - corticosteroids
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-258342
VL  - 195
IS  - 3
ER  -