drugset / Trial / NCT01055496
Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
Non-randomizedOpen-labelTreatment
Summary
This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.
Timeline
- Start
- 2010-03
- Primary completion
- 2013-07
- Completion
- 2014-03
Publications
- Sangha R, Davies A, Dang NH, Ogura M, MacDonald DA, Ananthakrishnan R, Paccagnella ML, Vandendries E, Boni J, Goh YT. Phase 1 study of inotuzumab ozogamicin combined with R-GDP for the treatment of patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma. J Drug Assess. 2017 Aug 16;6(1):10-17. doi: 10.1080/21556660.2017.1315336. eCollection 2017.
- Ogura M, Tobinai K, Hatake K, Davies A, Crump M, Ananthakrishnan R, Ishibashi T, Paccagnella ML, Boni J, Vandendries E, MacDonald D. Phase I Study of Inotuzumab Ozogamicin Combined with R-CVP for Relapsed/Refractory CD22+ B-cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2016 Oct 1;22(19):4807-4816. doi: 10.1158/1078-0432.CCR-15-2488. Epub 2016 May 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 37.5 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 50 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 375 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 550 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 500 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 0.8 mg/m2 | — |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 1.3 mg/m2 | — |
| Background | Dexamethasone | Small molecule | 40 mg | — |
| Background | Prednisone | Other / unclassified | 40 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | — |