drugset / Trial / NCT04882163
Study to Evaluate Tolerability of Iberdomide (CC-220) in Combination With Polatuzumab Vedotin Plus Rituximab or Tafasitamab or Rituximab Plus Chemotherapy in B-cell Lymphoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1b/2 randomized study of Iberdomide (CC-220) added to 3 different combination regimens (polatuzumab vedotin plus rituximab (Cohort A), tafasitamab (Cohort B), rituximab plus gemcitabine and platinum-based chemotherapy (Cohort C)) for participants with relapsed or refractory aggressive B-cell lymphoma (R/R a-BCL). All 3 cohorts will be open for enrollment at study start. Part 1 (dose escalation) will be followed by Part 2 (dose expansion), in which participants will be randomized to one of three cohorts, with CC-220 at the recommended Phase 2 Dose in combination with the Cohorts A, B and C treatment that is compared to their individual standard of care regimen.
Timeline
- Start
- 2021-10-10
- Primary completion
- 2026-04-08
- Completion
- 2029-04-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Iberdomide | Small molecule | — | — |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Dexamethasone | Small molecule | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Polatuzumab Vedotin | Other / unclassified | — | — |
| Background | Rituximab | Monoclonal antibody | — | — |
| Background | Tafasitamab | Monoclonal antibody | — | — |