A phase II, open-label, prospective, multicenter study to evaluate theefficacy and safety of subsequent treatment with the Zevalin(ibritumomab tiuxetan) study in patients with follicular grade I-IIlymphoma after 4 cycles of Fludarabine-Mitoxantrone-Rituximab(FMR) therapy. - ND

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 sitesMay 11, 2007

Overview

No summary available.

Registry

who.int

Start Date

May 11, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

•Histologically confirmed FL grade I\-II according to the REAL/WHO classification (from
•initial diagnosis made prior to starting FMR therapy);
•2\. FLIPI ? 3; 3
•3\. Central pathology review confirming the FL grade I\-II diagnosis and CD20 positivity, and
•no evidence/evidence with an infiltration \<25% of FL in bone marrow;
•4\. The first part of the treatment of FL must have been 4 cycles of standard FM chemotherapy
•(fludarabine 25 mg/m2/day on days 1 to 3 and mitoxantrone 10 mg/m2 on day 1\) in
•combination with rituximab (375 mg/m2\); Complete remission (CR), unconfirmed complete
•remission (CRu), partial response, and non\-responder according to the International
•Workshop Response Criteria for NHL described by Cheson et al (13\) after four cycles of

•1\. Presence of any other malignancy or history of prior malignancy except non\-melanoma skin
•tumors or stage 0 (in situ) cervical carcinoma;
•2\. Prior radioimmunotherapy, radiation therapy, or any other NHL therapy;
•3\. Presence of gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis;
•4\. Histological transformation of low\-grade NHL;
•5\. Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg);
•6\. Known history of HIV infection;
•7\. Abnormal liver function: total bilirubin \> 1\.5 x ULN or ALT \> 2\.5 x ULN within 1 week of
•8\. Abnormal renal function: serum creatinine \> 2\.0 x ULN within 1 week of accrual;
•9\. Nonrecovery from the toxic effects of FMR therapy;