Interim Analysis on a Dutch HOVON Multicenter Randomized Open Label Phase II Trial on 3 Rituximab Dosing Schemes In Chronic ITP Patients:

Jaap Jan Zwaginga, Ronnie van der Holt, Bart J Biemond, Peter A W Boekhorst, Mark Levin, Art Vreughdenhil, P C Huijgens, Anneke Brand, Rene van der Griend, Marleen Luten, Hans Pruijt, Okke de Weerdt, Elisabeth van Pampus, Sonja Zweegman, Rene Hollestein, Harry R Koene

Research output: Contribution to conferencePaperAcademic

Abstract

Abstract 2514 The overall short term effectivity of Rituximab in the treatment of ITP is reported to be around 50%. In most studies the traditional CD20 dosing scheme of 4 weekly interspaced 375 mg/m2 doses is used although other single-arm studies suggest comparable effectivity of lower doses. To investigate alternative dosing schemes, we conducted an open label phase II multicenter trial and randomized 156 ITP patients that were refractory for corticosteroid treatment, between three schemes. Questions were: are higher CD20 peak levels of value and is dose saving a feasible approach in early responding patients? The treatment arms were: A) 375 mg/m2 once a week for 4 weeks, B) 750 mg/m2 once a week for 2 weeks and C) 375 mg/m2 once a week for 2 weeks, in early and sustained responding patients (= within 15 days and still responding at 43 days) and another 2 x 375 mg/m2 to patients not fulfilling these criteria. In retrospect, seven of the 156 patients appeared ineligible at randomization and were therefore excluded from all analyses. Here we report on the best response within 71 days as primary end point for the first 105 patients that were included, i.e. 35 per treatment arm View this table: T1500400T1 So far, on the basis of the within 71 days overall response data, no superior dosing scheme of CD20 can yet be discerned. DisclosuresNo relevant conflicts of interest to declare
Original languageEnglish
Publication statusPublished - 2010

Cite this

Zwaginga, J. J., van der Holt, R., Biemond, B. J., Boekhorst, P. A. W., Levin, M., Vreughdenhil, A., ... Koene, H. R. (2010). Interim Analysis on a Dutch HOVON Multicenter Randomized Open Label Phase II Trial on 3 Rituximab Dosing Schemes In Chronic ITP Patients:.
Zwaginga, Jaap Jan ; van der Holt, Ronnie ; Biemond, Bart J ; Boekhorst, Peter A W ; Levin, Mark ; Vreughdenhil, Art ; Huijgens, P C ; Brand, Anneke ; van der Griend, Rene ; Luten, Marleen ; Pruijt, Hans ; de Weerdt, Okke ; van Pampus, Elisabeth ; Zweegman, Sonja ; Hollestein, Rene ; Koene, Harry R. / Interim Analysis on a Dutch HOVON Multicenter Randomized Open Label Phase II Trial on 3 Rituximab Dosing Schemes In Chronic ITP Patients:.
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title = "Interim Analysis on a Dutch HOVON Multicenter Randomized Open Label Phase II Trial on 3 Rituximab Dosing Schemes In Chronic ITP Patients:",
abstract = "Abstract 2514 The overall short term effectivity of Rituximab in the treatment of ITP is reported to be around 50{\%}. In most studies the traditional CD20 dosing scheme of 4 weekly interspaced 375 mg/m2 doses is used although other single-arm studies suggest comparable effectivity of lower doses. To investigate alternative dosing schemes, we conducted an open label phase II multicenter trial and randomized 156 ITP patients that were refractory for corticosteroid treatment, between three schemes. Questions were: are higher CD20 peak levels of value and is dose saving a feasible approach in early responding patients? The treatment arms were: A) 375 mg/m2 once a week for 4 weeks, B) 750 mg/m2 once a week for 2 weeks and C) 375 mg/m2 once a week for 2 weeks, in early and sustained responding patients (= within 15 days and still responding at 43 days) and another 2 x 375 mg/m2 to patients not fulfilling these criteria. In retrospect, seven of the 156 patients appeared ineligible at randomization and were therefore excluded from all analyses. Here we report on the best response within 71 days as primary end point for the first 105 patients that were included, i.e. 35 per treatment arm View this table: T1500400T1 So far, on the basis of the within 71 days overall response data, no superior dosing scheme of CD20 can yet be discerned. DisclosuresNo relevant conflicts of interest to declare",
keywords = "Arm, STAR, analysis, corticosteroid, patient",
author = "Zwaginga, {Jaap Jan} and {van der Holt}, Ronnie and Biemond, {Bart J} and Boekhorst, {Peter A W} and Mark Levin and Art Vreughdenhil and Huijgens, {P C} and Anneke Brand and {van der Griend}, Rene and Marleen Luten and Hans Pruijt and {de Weerdt}, Okke and {van Pampus}, Elisabeth and Sonja Zweegman and Rene Hollestein and Koene, {Harry R}",
year = "2010",
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Zwaginga, JJ, van der Holt, R, Biemond, BJ, Boekhorst, PAW, Levin, M, Vreughdenhil, A, Huijgens, PC, Brand, A, van der Griend, R, Luten, M, Pruijt, H, de Weerdt, O, van Pampus, E, Zweegman, S, Hollestein, R & Koene, HR 2010, 'Interim Analysis on a Dutch HOVON Multicenter Randomized Open Label Phase II Trial on 3 Rituximab Dosing Schemes In Chronic ITP Patients:'.

Interim Analysis on a Dutch HOVON Multicenter Randomized Open Label Phase II Trial on 3 Rituximab Dosing Schemes In Chronic ITP Patients: / Zwaginga, Jaap Jan; van der Holt, Ronnie; Biemond, Bart J; Boekhorst, Peter A W; Levin, Mark; Vreughdenhil, Art; Huijgens, P C; Brand, Anneke; van der Griend, Rene; Luten, Marleen; Pruijt, Hans; de Weerdt, Okke; van Pampus, Elisabeth; Zweegman, Sonja; Hollestein, Rene; Koene, Harry R.

2010.

Research output: Contribution to conferencePaperAcademic

TY - CONF

T1 - Interim Analysis on a Dutch HOVON Multicenter Randomized Open Label Phase II Trial on 3 Rituximab Dosing Schemes In Chronic ITP Patients:

AU - Zwaginga, Jaap Jan

AU - van der Holt, Ronnie

AU - Biemond, Bart J

AU - Boekhorst, Peter A W

AU - Levin, Mark

AU - Vreughdenhil, Art

AU - Huijgens, P C

AU - Brand, Anneke

AU - van der Griend, Rene

AU - Luten, Marleen

AU - Pruijt, Hans

AU - de Weerdt, Okke

AU - van Pampus, Elisabeth

AU - Zweegman, Sonja

AU - Hollestein, Rene

AU - Koene, Harry R

PY - 2010

Y1 - 2010

N2 - Abstract 2514 The overall short term effectivity of Rituximab in the treatment of ITP is reported to be around 50%. In most studies the traditional CD20 dosing scheme of 4 weekly interspaced 375 mg/m2 doses is used although other single-arm studies suggest comparable effectivity of lower doses. To investigate alternative dosing schemes, we conducted an open label phase II multicenter trial and randomized 156 ITP patients that were refractory for corticosteroid treatment, between three schemes. Questions were: are higher CD20 peak levels of value and is dose saving a feasible approach in early responding patients? The treatment arms were: A) 375 mg/m2 once a week for 4 weeks, B) 750 mg/m2 once a week for 2 weeks and C) 375 mg/m2 once a week for 2 weeks, in early and sustained responding patients (= within 15 days and still responding at 43 days) and another 2 x 375 mg/m2 to patients not fulfilling these criteria. In retrospect, seven of the 156 patients appeared ineligible at randomization and were therefore excluded from all analyses. Here we report on the best response within 71 days as primary end point for the first 105 patients that were included, i.e. 35 per treatment arm View this table: T1500400T1 So far, on the basis of the within 71 days overall response data, no superior dosing scheme of CD20 can yet be discerned. DisclosuresNo relevant conflicts of interest to declare

AB - Abstract 2514 The overall short term effectivity of Rituximab in the treatment of ITP is reported to be around 50%. In most studies the traditional CD20 dosing scheme of 4 weekly interspaced 375 mg/m2 doses is used although other single-arm studies suggest comparable effectivity of lower doses. To investigate alternative dosing schemes, we conducted an open label phase II multicenter trial and randomized 156 ITP patients that were refractory for corticosteroid treatment, between three schemes. Questions were: are higher CD20 peak levels of value and is dose saving a feasible approach in early responding patients? The treatment arms were: A) 375 mg/m2 once a week for 4 weeks, B) 750 mg/m2 once a week for 2 weeks and C) 375 mg/m2 once a week for 2 weeks, in early and sustained responding patients (= within 15 days and still responding at 43 days) and another 2 x 375 mg/m2 to patients not fulfilling these criteria. In retrospect, seven of the 156 patients appeared ineligible at randomization and were therefore excluded from all analyses. Here we report on the best response within 71 days as primary end point for the first 105 patients that were included, i.e. 35 per treatment arm View this table: T1500400T1 So far, on the basis of the within 71 days overall response data, no superior dosing scheme of CD20 can yet be discerned. DisclosuresNo relevant conflicts of interest to declare

KW - Arm

KW - STAR

KW - analysis

KW - corticosteroid

KW - patient

M3 - Paper

ER -

Zwaginga JJ, van der Holt R, Biemond BJ, Boekhorst PAW, Levin M, Vreughdenhil A et al. Interim Analysis on a Dutch HOVON Multicenter Randomized Open Label Phase II Trial on 3 Rituximab Dosing Schemes In Chronic ITP Patients:. 2010.