Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 629
- 主要终点
- To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients
研究概览
简要总结
The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission.
详细描述
Patients with Stage III-IV follicular lymphoma and tumor > 2cm (Stage II allowed if tumor > 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Diagnosis of indolent follicular lymphoma(follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes) with surface IgM or IgG phenotype.
- •Stage III-IV with lymph node > 2cm or Stage II with lymph node > 5 cm
- •No prior chemotherapy other than local radiation (not greater than 2 sites)
- •ECOG < 2
- •Survival > 1 yr
- •Serum creatinine < 1.5 mg/dl
- •Bilirubin <1.5 mg/dl
- •SGOT/SGPT < 3.5 ULN
- •No HIV antibodies or HBV antigen
- •Negative pregnancy screen (females)
- •No unrelated neoplasm in the previous 10 years
- •No evidence of primary or secondary CNS lymphoma
结局指标
主要结局
To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients
时间窗: until date of relapse
次要结局
- To determine the ability of the idiotype vaccine to produce a molecular complete remission(once subject achieves molecular CR)
- To determine the impact of molecular disease free survival(until relapse)
- To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor(varies)
- To compare the overall survival of subjects randomized to receive either treatment(minimum 5 years from last subject randomized)
- To confirm the safety of 5 monthly injections of the vaccine with GM-CSF(4 days)