Non-Hodgkin's Lymphoma
Conditions
Keywords
Lymphoma, Non-Hodgkin, Rituximab Refractory, Rituximab Failure, Indolent Non-Hodgkins Lymphoma
Brief summary
SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.
Interventions
DRUGBendamustine HCl
Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.
Sponsors
Cephalon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ELIGIBILITY: Key Inclusion Criteria * Documented B-cell Non-Hodgkin's Lymphoma * Small lymphocytic lymphoma (ALC \< 5,000 cells/mm3) * Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types) * Lymphoplasmacytic lymphoma * Follicular center lymphoma, follicular Disease documented to be refractory to a full-course of the most recent rituximab therapy (single agent or combination) * At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens * Bidimensionally measurable disease (by CT scan) with at least one lesion measuring ≥ 2.0 cm in a single dimension Key
Exclusion criteria
* Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (Zevalin®) will not be eligible * History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| • assess the safety profile of Treanda in this patient population. • assess the duration of progression-free survival (PFS). • estimate the basic pharmacokinetic parameters • assess the effects of plasma concentrations | 6 months |
Countries
Canada, Puerto Rico, United States
Outcome results
None listed