drugset / Trial / NCT01322776
Combination of Bortezomib, Fludarabine and Cyclophosphamide Treat Recurrent Mantle Cell Lymphoma
Phase 1/2
Unknown
40 enrolled
Sun Yat-sen University
Fudan University · collabJiangsu Cancer Institute & Hospital · collabPeking University Cancer Hospital & Institute · collabRuijin Hospital · collabTianjin Medical University Cancer Institute and Hospital · collabWest China Hospital · collabZhejiang University · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multi-center, single arm, open-label, prospective IIS study, which will enroll 40 recurrent MCL patients.The aim is to evaluate the efficacy and safety of bortezomib, fludarabine and cyclophosphamide treatment and also analyze the relationship between NF-kB activity and efficacy of bortezomib treatment and whether NF-kB activity can predict MCL progression.
Timeline
- Start
- 2011-03
- Primary completion
- 2013-10
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 150 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 250 mg/m2 | Intravenous |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |