Safety and Efficacy of Blinatumomab in Adults With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

March 13, 2017

Primary Completion Date

April 4, 2019

Study Completion Date

October 28, 2019

Conditions
High-risk Diffuse Large B-Cell Lymphoma
Interventions
DRUG

Blinatumomab

Blinatumomab monotherapy was supplied in single-use sterile glass injection vials and administered as an IV infusion.

DRUG

Investigator's Choice Chemotherapy

"During the run-in period participants received 6 cycles of standard of care rituximab-chemotherapy dosed per investigator's institution standard as follows:~* R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine,prednisone)~* R-DA-EPOCH (rituximab and dose adjusted-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) or~* R-CHOEP (rituximab and cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide)."

DRUG

Dexamethasone

Dexamethasone 20 mg IV: within 1 hour prior to start of treatment in each treatment cycle, and within 1 hour prior to dose-step (increase).

Trial Locations (24)

15006

Research Site, A Coruña

21201

Research Site, Baltimore

28007

Research Site, Madrid

29607

Research Site, Greenville

37007

Research Site, Salamanca

41013

Research Site, Seville

46026

Research Site, Valencia

60153

Research Site, Maywood

60612

Research Site, Chicago

70112

Research Site, New Orleans

73104

Research Site, Oklahoma City

75475

Research Site, Paris

89081

Research Site, Ulm

94010

Research Site, Créteil

97213

Research Site, Portland

08903

Research Site, New Brunswick

T6G 1Z2

Research Site, Edmonton

P6B 0A8

Research Site, Sault Ste. Marie

M5G 2M9

Research Site, Toronto

01307

Research Site, Dresden

08003

Research Site, Barcelona

08907

Research Site, L'Hospitalet de Llobregat

BS2 8ED

Research Site, Bristol

S10 2JF

Research Site, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY