MedTrace Logo

Fludarabine,Cyclophosphamide and Rituximab Followed by Zevalin for Non-Follicular Indolent Lymphomas.

NCT00354822 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2009-09-18

No results posted yet for this study

Summary

Pilot multicentre, open label study with the aim to evaluate antitumor activity in term of the sum of complete and partial response (O.R.R.) of chemotherapy (cyclophosphamide and fludarabine) and rituximab, followed by zevalin radioimmunotherapy and response duration (Time to relapse or progression)and to evaluate the safety of the treatment as acute and late toxicity.

Secondary objective is to evaluate the overall survival (OS) and the event-free survival (EFS).

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

DRUG

Zevalin

Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with baseline platelet counts\>150x10\^9/L or 0.3 mCi/kg for patients with baseline platelet counts of 100 to 149x10\^9/L. Rituximab 250mg/sqm is given prior to therapeutic radiolabeled antibodies.

Sponsors & Collaborators

  • Regional Hospital of Bolzano

    collaborator OTHER

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Principal Investigators

  • Cortelazzo Sergio, MD · Ospedale Centrale di Bolzano (Italy)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Italy

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 NCT00354822 on ClinicalTrials.gov