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Clinical Trial to Evaluate R-COMP Versus R-CHOP in Newly Diagnosed Patients With Non-localised Diffuse Large B-cell Lymphoma (DLBCL)/Follicular Lymphoma Grade IIIb

NCT02012088 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2024-02-26

No results posted yet for this study

Summary

The Phase II study proposed here assesses the hypothesis that replacing doxorubicin by Myocet® in the R-CHOP regimen would yield comparable antitumour efficacy with a lower cardiotoxicity for first-line treatment in elderly patients with non-localised DLBCL/Follicular lymphoma grade IIIb

Conditions

Interventions

DRUG

RCOMP

Day 1: Rituximab 375 mg/m2; Myocet® 50 mg/m2; cyclophosphamide 750 mg/m2; vincristine 1.4 mg/m2 (maximum 2 mg); prednisone 60 mg/m2 Days 2-5: Prednisone, 60 mg/m2 Administered every 21 days × 6 cycles

DRUG

RCHOP

Day 1: Rituximab 375 mg/m2; Doxorubicin 50 mg/m2; cyclophosphamide 750 mg/m2; vincristine 1.4 mg/m2 (maximum 2 mg); prednisone 60 mg/m2 Days 2-5: Prednisone, 60 mg/m2 Administered every 21 days × 6 cycles

Sponsors & Collaborators

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    lead OTHER

Principal Investigators

  • Dr. Alejandro Martin · University of Salamanca

  • Dr. Juan Manuel Sancho · Germans Trias i Pujol Hospital

  • Dr. Francisco Gual · Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-11
Primary Completion
2016-10-31
Completion
2021-08-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT02012088 on ClinicalTrials.gov