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TREatment of degeNerative and Neoplastic Diseases With Rituximab

NCT01277172 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2011-01-14

No results posted yet for this study

Summary

This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated patients with diffuse B cells Non Hodgkin lymphoma.

Conditions

Interventions

BIOLOGICAL

Rituximab

375 mg/m2 IV every 2 weeks for 6 cycles

BIOLOGICAL

Rituximab

375 mg/m2 IV every 2 weeks for 6 cycles

BIOLOGICAL

Rituximab

375 mg/m2 IV every 2 weeks for 6 cycles

BIOLOGICAL

Rituximab

375 mg/m2 IV every 14 days for 6 cycles

Sponsors & Collaborators

  • Probiomed S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Jorge Revilla Beltri, MD · Probiomed S.A. de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs
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 NCT01277172 on ClinicalTrials.gov