drugset / Trial / NCT02983097
Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP
Phase 1/2
Terminated
34 enrolled
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Amgen · collabCelgene Corporation · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this study is to evaluate efficacy and safety of the combination of lenalidomide, an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment, called R-DHAP. R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy consisting of Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based chemotherapy, either cisplatinum, or, if treatment with cisplatinum is contraindicated, carboplatinum.
Timeline
- Start
- 2010-11
- Primary completion
- 2014-01
- Completion
- 2015-04-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 5 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 20 mg | Oral |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |