drugset / Trial / NCT00801918
Denileukine Diftitox for Relapsed ALCL
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine is Denileukin diftitox will be safe, well tolerated and induce a significant overall response alone and in combination with chemotherapy: ifosfamide, carboplatin and etoposide (ICE) and will be safe and well tolerated in a population of children, adolescents and young adults with relapsed or refractory anaplastic large cell lymphoma (ALCL).
Timeline
- Start
- 2008-12
- Primary completion
- 2011-12
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 635 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Etoposide | Small molecule | 100 mg/m2 | — |
| Subject | Ifosfamide | Small molecule | 3000 mg/m2 | Intravenous |
| Subject | denileukin diftitox | Protein / enzyme biologic | 18 ug/kg | — |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 3000 mg/m2 | — |