drugset / Trial / NCT00632827
Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)
Phase 2
Terminated
21 enrolled
University of California, San Francisco
Eisai Inc. · collabWashington University School of Medicine · collab
NaSingle-groupOpen-labelTreatment
Summary
This study examines the use of denileukin diftitox (Ontak) for patients with peripheral T-cell lymphoma who are candidates for autologous stem cell transplants.
Timeline
- Start
- 2008-07-01
- Primary completion
- 2014-06-23
- Completion
- 2016-06-23
Outcome
Outcome not reported
Stopped: “Manufacturing shortage of both Diftitox and Doxil”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 100 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 2000 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 15 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Subject | Etoposide | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 60 mg/kg | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Methotrexate | Small molecule | 3000 mg/m2 | Intravenous |
| Subject | Navelbine | Unknown | 20 mg/m2 | — |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | — |
| Subject | carmustine | Small molecule | 550 mg/m2 | — |
| Subject | denileukin diftitox | Protein / enzyme biologic | 9 ug/kg | — |
| Subject | denileukin diftitox | Protein / enzyme biologic | 18 ug/kg | — |
| Background | Granulocyte-colony stimulating factor (G-CSF) | Protein / enzyme biologic | 10 ug/kg | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |