Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Number of Participants With Overall Survival (10 Years) by Treatment
研究概览
简要总结
The goal of this clinical research study is to compare chemotherapy given with rituximab to chemotherapy followed by rituximab. The safety of both treatment schedules will be studied. Laboratory tests of genetic changes in blood and bone marrow before and during the study will also be monitored.
详细描述
Rituximab is a monoclonal antibody that is designed to attach to leukemia cells and activate a series of events that may cause the cancer cells to die.
Fludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying.
Mitoxantrone is designed to stop cancer cells from making DNA, which may stop the cells from making more cells.
Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer.
Study Groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 76 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated stage IV indolent B-cell lymphoma [Amendment May 2001: eligibility restricted to follicular lymphoma]
排除标准
- 未提供
研究组 & 干预措施
1: FND + Rituximab Followed by Interferon
Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon
干预措施: Fludarabine (Drug)
1: FND + Rituximab Followed by Interferon
Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon
干预措施: Novantrone (Drug)
1: FND + Rituximab Followed by Interferon
Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon
干预措施: Decadron (Drug)
1: FND + Rituximab Followed by Interferon
Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon
干预措施: Rituximab (Drug)
1: FND + Rituximab Followed by Interferon
Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon
干预措施: Interferon (Drug)
2: FND Followed by Interferon & Rituximab
Fludarabine/Novantrone/Decadron Followed by Interferon & Rituximab
干预措施: Fludarabine (Drug)
2: FND Followed by Interferon & Rituximab
Fludarabine/Novantrone/Decadron Followed by Interferon & Rituximab
干预措施: Novantrone (Drug)
2: FND Followed by Interferon & Rituximab
Fludarabine/Novantrone/Decadron Followed by Interferon & Rituximab
干预措施: Decadron (Drug)
2: FND Followed by Interferon & Rituximab
Fludarabine/Novantrone/Decadron Followed by Interferon & Rituximab
干预措施: Rituximab (Drug)
2: FND Followed by Interferon & Rituximab
Fludarabine/Novantrone/Decadron Followed by Interferon & Rituximab
干预措施: Interferon (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Novantrone (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Decadron (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Rituximab (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Interferon (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Doxorubicin (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Vincristine (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Bleomycin (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Cyclophosphamide (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Etoposide (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Cisplatin (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Ara-C (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Methyl-Prednisolone (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Procarbazine (Drug)
3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon
Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon
干预措施: Prednisone (Drug)
结局指标
主要结局
Number of Participants With Overall Survival (10 Years) by Treatment
时间窗: 10 Years
Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years.
次要结局
- Number of Participants With Progression Free Survival (10 Years) by Treatment(10 years)