drugset / Trial / NCT04432714
Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement
NaSingle-groupOpen-labelTreatment
Summary
The prognosis of DLBCL with MYC rearrangement is dismal. Previous study showed that lenalidomide in combination with R-CHOP showed promising therapeutic activity and that R-DA EPOCH was superior compared to R-CHOP regimen in this cohort of patients. The investigators therefore design this phase I/II study to investigate the safety and efficacy of lenalidomide in combination with R-DA EPOCH in patients with untreated MYC-rearranged DLBCL.
Timeline
- Start
- 2020-06-09
- Primary completion
- 2024-12-31
- Completion
- 2026-12-31
Publications
- Background Godfrey JK, Nabhan C, Karrison T, Kline JP, Cohen KS, Bishop MR, Stadler WM, Karmali R, Venugopal P, Rapoport AP, Smith SM. Phase 1 study of lenalidomide plus dose-adjusted EPOCH-R in patients with aggressive B-cell lymphomas with deregulated MYC and BCL2. Cancer. 2019 Jun 1;125(11):1830-1836. doi: 10.1002/cncr.31877. Epub 2019 Feb 1.
- Background Coiffier B, Sarkozy C. Diffuse large B-cell lymphoma: R-CHOP failure-what to do? Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):366-378. doi: 10.1182/asheducation-2016.1.366.
- Background Dunleavy K, Fanale MA, Abramson JS, Noy A, Caimi PF, Pittaluga S, Parekh S, Lacasce A, Hayslip JW, Jagadeesh D, Nagpal S, Lechowicz MJ, Gaur R, Lucas A, Melani C, Roschewski M, Steinberg SM, Jaffe ES, Kahl B, Friedberg JW, Little RF, Bartlett NL, Wilson WH. Dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) in untreated aggressive diffuse large B-cell lymphoma with MYC rearrangement: a prospective, multicentre, single-arm phase 2 study. Lancet Haematol. 2018 Dec;5(12):e609-e617. doi: 10.1016/S2352-3026(18)30177-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 10 mg | — |
| Subject | Lenalidomide | Other / unclassified | 15 mg | — |
| Subject | Lenalidomide | Other / unclassified | 20 mg | — |
| Subject | Lenalidomide | Other / unclassified | 25 mg | — |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 10 mg/m2 | — |
| Background | Etoposide | Small molecule | 50 mg/m2 | — |
| Background | Prednisone | Other / unclassified | 60 mg/m2 | Oral |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Vincristine | Small molecule | 0.4 mg/m2 | — |