drugset / Trial / NCT03141203
Evaluation of the Combination of Romidepsin and Carfilzomib in Relapsed/Refractory Peripheral T Cell Lymphoma Patients
Phase 1/2
Completed
50 enrolled
University of Birmingham
Amgen · collabBloodwise · collabCelgene Corporation · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a multicentre phase I/II trial looking at the combination of romidepsin and carfilzomib. The aim of the phase I part is to determine the maximum tolerated dose (MTD) of the combination. This part will recruit up to 27 patients, plus possibly an additional 3 patients at the MTD. The aim of the phase II part is to assess the activity of the combination at the maximum tolerated dose in 28 patients (including at least 6 patients treated at the MTD from phase I). Patients will receive 8 cycles of romidepsin with carfilzomib and response will be assessed every second cycle. Patients will be followed up for progression and survival until the end of the trial.
Timeline
- Start
- 2015-07-13
- Primary completion
- 2020-08
- Completion
- 2021-09-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 36 mg/m2 | — |
| Subject | Carfilzomib | Other / unclassified | 45 mg/m2 | — |
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | — |
| Subject | Romidepsin | Peptide | 8 mg/m2 | — |
| Subject | Romidepsin | Peptide | 10 mg/m2 | — |
| Subject | Romidepsin | Peptide | 12 mg/m2 | — |
| Subject | Romidepsin | Peptide | 14 mg/m2 | — |