NCT00354822

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

Phase II Study for Use of Oral Fludarabine Plus Cyclophosphamide and Rituximab Followed by Zevalin as Front-Line Treatment for Non-Follicular Indolent Lymphomas.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: A.O. Ospedale Papa Giovanni XXIII · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Test medication: * 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. * Standard dose chemotherapy consisting of cyclophosphamide, fludarabine and rituximab given every 28 days up to the best response (maximum 6 courses). * A prophylaxis for pneumocystis carinii as well as for herpes zoster are needed during treatment. Main parameters of activity: activity of Yttrium-90 (90Y) ibritumomab tiuxetan after cyclophosphamide, fludarabine and rituximab combination.

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2006-07-20
• Last updated: 2009-09-18

Locations

6 sites across 1 country: Italy