EUCTR2005-003836-22-GB进行中（未招募）1 期
A Phase III, Randomized, Double-Blind Study of Galiximab in Combination with Rituximab Compared with Rituximab in Combination with Placebo for the Treatment of Subjects with Relapsed or Refractory, Follicular Non Hodgkin’s Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 742
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be considered for registration and randomization into this study, subjects must satisfy all of the following criteria:
- •1. Must give written informed consent and any authorizations as required by local law
- •2. Aged =18 years old at the time of informed consent
- •3. Histologically confirmed follicular Grade 1-3a NHL. If slides and/or tissue blocks
- •from the most recent lymph biopsy are not available for Central Pathology Review, a
- •repeat lymph node biopsy is required prior to enrollment. If there is any clinical
- •evidence suggesting transformation (e.g. elevated LDH >2× upper limit of normal),
- •a biopsy is required within 6 months prior to enrollment. Subjects with evidence of
- •histologic transformation on a repeat biopsy are excluded from this study.
- •4. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment as determined by one of the following:
- •- Documented disease progression by CT scan using the International Workshop Response Criteria (IWRC) as described in protocol Appendix C
- •- The presence of B symptoms
- •- Bulky disease (at least 1 lesion >5 cm)
- •- Laboratory abnormalities (cytopenias)
- •- Presence of masses which are causing ongoing clinical symptoms
- •5. Bidimensionally measurable disease with at least 1 lesion =2.0 cm in a single dimension
- •6. Hematologic, hepatic, and renal function parameters satisfying the following:
- •- Bilirubin =2.0 mg/dL
- •- AST (SGOT) =2 x upper limit of normal (ULN) and ALT (SGPT) = 2 x ULN
- •- Serum creatinine = 2.0 mg/dL
- •- Hemoglobin = 8.0 g/dL
- •- Absolute neutrophil count = 1500 cells/mm3
- •- Platelet count = 75,000 plts/mm3
- •7. WHO Performance Status = 2
- •8. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs
- •9. Expected survival of = 3 months
- •10. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Unless otherwise specified, candidates will be excluded from study entry if any of the
- •following exclusion criteria exist at the time of randomization:
- •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 TTP of less than 6 months)
- •5. Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to
- •Study Day 1 (6 weeks if nitrosourea or mitomycin-C)
- •6. Prior lymphoma vaccine therapy within 12 months prior to Study Day 1
- •7. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1
- •8. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1
- •9. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1
- •10. Prior allogeneic transplant
- •11. Transfusion-dependent subjects
- •12. Known history of hepatitis or hepatic disease. (Although testing for hepatitis B is not mandatory, this should be considered for all subjects considered at high risk for hepatitis B infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B exposure should be excluded unless the serological findings are clearly due to vaccination.)
- •13. Presence of chronic lymphocytic leukemia (CLL), marginal zone lymphoma,
- •mucosa-associated lymphoid tissue (MALT)
- •14. Presence of central nervous system (CNS) 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 in the opinion of the Investigator and/or the Sponsor
- •21. New York Heart Association Class III or IV cardiac disease or myocardial infarction
- •within 6 months prior to Study Day 1
- •22. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
- •23. History of alcoholism or substance abuse within the 2 years prior to Study Day 1
- •24. Pregnant or currently breastfeeding
研究者
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