| | Requirement |
| 1 | 18 y/o and above. |
| 2 | Histologically confirmed follicular non-Hodgkin's lymphoma (NHL) Gr 1-3a. If pt received any intervening lymphoma treatment since the most recent biopsy, repeat biopsy is required to exclude transformation. |
| 3 | Relapsed or progressive disease after at least 1 prior chemotherapy, requiring treatment as determined by 1 of the following:
a) Documented progression by CT using International Workshop Response Criteria b) Presence of B symptoms c) Bulky disease (at least 1 lesion > 5 cm) d) Lab abnormalities (cytopenias) e) Presence of masses which are causing ongoing clinical symptoms
|
| 4 | Bidimensionally measurable disease with at least 1 lesion 2.0 cm or greater in a single dimension. |
| 5 | Bilirubin 2.0 mg/dL or less; AST & ALT 2.0 (or less) x ULN
|
| 6 | Serum creatinine 2.0 or less. |
| 7 | Hgb 8.0 or greater; absolute neutrophil count 1500 or greater; Platelets 75,000 or greater. |
| 8 | WHO performance status 0-2. |
| 9 | Recovered fully from any significant toxicity associated with prior surgery, radiotherapy, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs. |
| 10 | Expected survival of 3 mos or more. |
| 11 | Patients of reproductive potential must agree to use accepted birth control methods during treatment & for 12 mos after completion of therapy. |
| 12 | Signed Informed Consent, including HIPAA authorization. |
| 1 | Follicular lymphoma Grade 3b. |
| 2 | Previous exposure to galiximab or any anti-CD80 antibody. |
| 3 | Known hypersensitivity to murine proteins. |
| 4 | Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a time to progression of < 6 mos). |
| 5 | Cancer radiotherapy, biological therapy, or chemotherapy within 3 wks prior to day 1; 6 wks if nitrosourea or mitomycin-C
|
| 6 | Prior lymphoma vaccine treatment within 12 mo prior to day 1. |
| 7 | Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 wks prior to day 1. |
| 8 | Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to day 1. |
| 9 | Autologous bone marrow or stem cell transplant within 6 months prior to day 1. |
| 10 | Prior allogeneic transplant. |
| 11 | Transfusion-dependent patients. |
| 12 | Known history of hepatitis or hepatic disease. Hep B testing not mandatory, but should be considered for those at high risk for Hep B & in endemic areas. Patients with serological evidence of current or past Hep B exposure should be excluded unless findings are clearly due to vaccination.
|
| 13 | Presence of CLL, marginal zone lymphoma, mucosa-associated lymphoid tissue (MALT). |
| 14 | Presence of central nervous system lymphoma. |
| 15 | Known history of HIV infection or AIDS. |
| 16 | Prior diagnosis of aggressive NHL or mantle-cell lymphoma. |
| 17 | Histologic transformation. |
| 18 | Presence of pleural or peritoneal effusion with positive cytology for lymphoma. |
| 19 | Another primary malignancy requiring active treatment (except hormonal therapy). |
| 20 | Serious nonmalignant disease (e.g. congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions which would compromise protocol objectives. |
| 21 | NYHA Class III or IV cardiac disease or heart attack within 6 mos prior to day 1. |
| 22 | Major surgery, except diagnostic surgery, within 4 weeks prior to day 1. |
| 23 | History of alcoholism or substance abuse within the 2 yrs prior to day 1. |
| 24 | Pregnant or breastfeeding females. |
