Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL

Genzyme

Status and phase

Completed

Phase 2

Conditions

Lymphoma, Low-Grade

Treatments

Drug: Rituximab

Drug: Fludarabine Phosphate (Fludara)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00311129

91456

309123

Details and patient eligibility

About

The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma.

Full description

As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

Enrollment

41 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with CD 20 positive, relapsed/refractory indolent lymphoma. (Regimens of prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are allowed.)
Patients with measurable lesions (> 1.5 cm).
Patients who have not received any treatment for more than 4 weeks after completing previous therapies (6 months in the case of antibody therapies).
ECOG performance status: 0 - 1
Patients with adequately maintained organ functions.

Exclusion criteria

Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency, serious CNS symptoms, fever </=38 °C, interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune hemolytic anemia or the history of the disease, or glaucoma.
Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
Patients who received G-CSF or transfusion within 1 week before the registration.
Patients with the history of allergies to purine nucleoside analogue.
Patients who experienced serious hypersensitivity or anaphylaxis to rituximab or mouse protein-derived products.
Patients who had ever received prior therapy with fludarabine phosphate injection, pentostatin, cladribine, SH T 586, blood stem cell transplant, or monoclonal antibody therapy other than rituximab to NHL (including radioimmunotherapy).
Patients who had progressive disease within 6 months of receiving therapy including rituximab.
Women who are pregnant, of childbearing potential, or lactating.
Patients who do not agree to practice contraception.