MedTrace Logo

FCM Versus R-FCM Followed by R-Maintenance or Observation Only

NCT00317096 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2021-05-07

No results posted yet for this study

Summary

The aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy (R-FCM) versus FCM chemotherapy alone for remission induction and to asses the safety and efficacy of rituximab maintenance versus observation only after response to induction therapy. Both questions are addressed in way of a prospective randomized comparison in patients with relapsed FL, MCL and LP lymphoma.

Conditions

  • Lymphoma, Follicular
  • Lymphoma, Low-Grade
  • Lymphoma, Intermediate-Grade

Interventions

PROCEDURE

FCM

Active comparator: Chemotherapy

PROCEDURE

R-FCM

experimental: Chemotherapy with additional rituximab

DRUG

rituximab maintenance

2 courses of rituximab maintenance after completion of salvage therapy

OTHER

observation only

no Intervention after completion of FCM or R-FCM

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Hiddemann Wolfgang, PhD · University Hospital Großhadern/LMU, Dept. of Medicine III

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-11-30
Primary Completion
2001-06-30
Completion
2021-06-30

Countries

  • Germany

Study Locations

More Related Trials

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 NCT00317096 on ClinicalTrials.gov