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OPTIMAL>60 / DR. CHOP, Improvement of Therapy of Elderly Patients with CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine

NCT01478542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1152

Last updated 2025-01-08

No results posted yet for this study

Summary

The purpose of this study is to improve the outcome of elderly patients with CD20-Aggressive B-Cell Lymphoma and to reduce the toxicity of standard used Immuno-Chemotherapy by using an optimised schedule of the monoclonal antibody Rituximab, substituting conventional by Liposomal Vincristine and by a PET-guided reduction of therapy in Combination with Vitamin D Substitution.

Conditions

  • CD20+ Aggressive B-Cell Lymphoma

Interventions

DRUG

Conventional Vincristine

DRUG

Liposomal Vincristine

DRUG

Ricover-scheme rituximab

DRUG

optimised rituximab-schedule

Sponsors & Collaborators

  • German High-Grade Non-Hodgkin's Lymphoma Study Group

    collaborator OTHER

  • Spectrum Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Universität des Saarlandes

    lead OTHER

Principal Investigators

  • Lorenz Thurner, Professor · Saarland University, Saarland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2024-01-18
Completion
2024-01-18

Countries

  • Germany

Study Locations

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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 NCT01478542 on ClinicalTrials.gov