Non-Hodgkin's Lymphoma
Conditions
Keywords
Non-Hodgkin's Lymphoma, NHL, Rituxan, Mantle Cell, mabs
Brief summary
SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression. RATIONALE: Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients. PURPOSE: This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.
Interventions
Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.
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
Documented B-Cell NHL or mantle cell lymphoma * CD-20+ tumor * Indolent NHL: follicular B-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma * Maximum of three prior chemotherapy regimens * Age of at least 18 years at Screening Visit (Site specific requirement may differ)
Exclusion criteria
* Refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination) * Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously * Use of investigational agents within 28 days of study * History of prior high dose chemotherapy with allogeneic stem cell support * History of prior radioimmunotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma | 4-6 months |
Secondary
| Measure | Time frame |
|---|---|
| • To characterize the safety profile of SDX-105 plus rituximab in this patient population • To determine the one-year and Kaplan-Meier estimates of progression-free survival (PFS) rates • To determine the median duration of response (DR) | 4-6 months |
Countries
Australia, Canada, United States
Outcome results
None listed