Efficacy/Safety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.

PHASE2CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

October 3, 2013

Primary Completion Date

January 31, 2018

Study Completion Date

August 31, 2018

Conditions
Diffuse, Large B-Cell, Lymphoma
Interventions
DRUG

Bortezomib

Bortezomib: subcutaneous, 1,3 mg/m2, day 1, 8, 15.

DRUG

Rituximab

Rituximab: intravenous, 375 mg/m2, day 1

DRUG

Cyclophosphamide

Cyclophosphamide: intravenous, 750 mg/m2, day 1

DRUG

Doxorubicin

Adriamycin:intravenous, 50 mg/m2, day 1

DRUG

Prednisone

Prednisone: oral, 100 mg, days 1-5

DRUG

Vincristine

Vincristine: intravenous, 1,4 mg/m2, day 1

Trial Locations (21)

11407

Hospital de Jerez, Jerez de la Frontera

17007

Hospital Universitari de Girona Doctor Josep Trueta, Girona

28031

Hospital Universitario Infanta Leonor, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Centro Integral Oncológico Clara Campal, Madrid

28922

Hospital Universitario Fundación Alcorcón, Alcorcón

33006

Hospital Universitario Central de Asturias, Oviedo

36036

Complejo Hospitalario Universitario de Vigo, Vigo

37007

Hospital Universitario de Salamanca, Salamanca

38320

Hospital Universitario de Canarias, Santa Cruz de Tenerife

39008

Hospital Universitario Marqués de Valdecilla, Santander

41013

Hospital Universitario Virgen del Rocío, Seville

46017

Hospital Universitario Doctor Peset, Valencia

46026

Hospital Universitari i Politècnic La Fe, Valencia

50009

Hospital Clínico Universitario Lozano Blesa, Zaragoza

07198

Hospital Son Llàtzer, Palma

08916

Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona

08908

Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet de Llobregat

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

All Listed Sponsors
collaborator

Janssen-Cilag, S.A.

INDUSTRY

lead

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

NCT01848132 - Efficacy/Safety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI. | Biotech Hunter | Biotech Hunter