MedTrace Logo

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

NCT01848132 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2018-09-19

No results posted yet for this study

Summary

Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for between 30% and 50% of the patients. Although it is considered a curable disease, still at least 40 % of the patients will fail first line chemotherapy. The International Prognostic Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to identify patients with different outcome.

There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The survival of these patients remains poor, with EFS around 40%.

The combination of RCHOP with new drugs is an attractive approach to treat these patients.

The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2 years, with a diagnosis of DLBCL with an aIPI \> 1 or an aIPI =1 with increased levels of beta-2-microglobulin (above the Upper Limits of Normal.)

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

Sponsors & Collaborators

  • Janssen-Cilag, S.A.

    collaborator INDUSTRY

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    lead OTHER

Principal Investigators

  • Eva González, MD · Institut Catalá d'Oncología, Hospital Duran i Reynals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-03
Primary Completion
2018-01-31
Completion
2018-08-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01848132 on ClinicalTrials.gov