Fludarabine,Cyclophosphamide and Rituximab Followed by Zevalin for Non-Follicular Indolent Lymphomas. (Z0105)
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study for Use of Oral Fludarabine Plus Cyclophosphamide and Rituximab Followed by Zevalin as Front-Line Treatment for Non-Follicular Indolent Lymphomas.|
- achievement and duration of complete or partial reduction of lymphnodes six weeks after the end of treatment with zevalin [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- overall and event free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
|Study Completion Date:||August 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
- 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.
|USC Ematologia Ospedali Riuniti di Bergamo|
|Bergamo, BG, Italy, 24128|
|U.O. Ematologia Ospedali Civili Brescia|
|Brescia, BS, Italy|
|Medicina Nucleare ed Oncologia Medica AOU Policlinico Universitario di Messina|
|Messina, ME, Italy, 98125|
|Istituto per la Ricerca e la Cura del Cancro IRCC|
|Candiolo, TO, Italy, 10060|
|SC Ematologia 2 ASO S. Giovanni Battista|
|Torino, TO, Italy|
|U.O. Ematologia Ospedale Cà Foncello|
|Treviso, TV, Italy, 31100|
|Principal Investigator:||Cortelazzo Sergio, MD||Ospedale Centrale di Bolzano (Italy)|