Lymphoma, Low-Grade
Conditions
Brief summary
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.
Detailed 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.
Interventions
Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
DRUGRituximab
Injection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | The best response until the end of 6th treatment cycle |
Secondary
| Measure | Time frame |
|---|---|
| CR rate | CR or CRu until the end of 6th treatment cycles |
| Progression free survival | Progression or death which comes earlier, observed until 12 weeks after the completion of the treatment in the last patient |
| Overall survival | Death, observed until 12 weeks after the completion of the treatment in the last patient |
Countries
Japan
Outcome results
None listed