Non-Hodgkins Lymphoma
Conditions
Brief summary
In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma. Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination of rituximab and short course chemotherapy will allow the use of additional active agent with a unique mechanism of cytotoxicity. In addition, debulking of lymphoma prior to 90Y Zevalin administration may minimize the myelotoxicity of this agent.
Detailed description
Upon determination of eligibility, patients will be receive: * Rituxan + CHOP or CVP + Ibritumomab Tiuxetan Patients who are considered medical candidates for doxorubicin should receive CHOP chemotherapy (Cyclophosphamide, doxorubicin, vincristine and prednisone). Patients who are not considered medical candidates for doxorubicin should receive CVP chemotherapy (Cyclophosphamide, Vincristine, and prednisone)
Interventions
Sponsors
Biogen
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in this study, you must meet the following criteria: * Histologic documentation of follicular center, B-cell lymphoma * Early stage lymphoma (stages I or II) relapsed after radiation therapy alone * No previous chemotherapy or monoclonal antibody therapy * Measurable or evaluable disease * Able to perform activities of daily living with minimal assistance * Age \> 18 years * Adequate bone marrow ,liver and kidney function * Must be accessible for treatment and follow-up. * Bone marrow examination initial staging and accurate restaging * All patients must give written informed consent prior to study entry.
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Small lymphocytic (CLL type) lymphomas and CLL * Impaired bone marrow reserve * Female pregnant or lactating * Serious active infection at the time of treatment * Any other serious underlying condition * Central nervous system involvement (brain or meningeal) * HIV or AIDS-related lymphoma * Received prior external beam radiation therapy to \> 25% of active bone marrow * Pleural effusion * Received prior murine antibodies or proteins * History of other neoplasms within five years of diagnosis Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall clinical response rate | — |
| Overall molecular response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Overall survival | — |
| Overall toxicity | — |
Outcome results
None listed