drugset / Trial / NCT03736616
Acalabrutinib Plus RICE for Relapsed/Refractory DLBCL
Non-randomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the tolerability,feasibility, and efficacy of combining acalabrutinib with RICE chemotherapy as second line therapy in relapsed/refractory DLBCL patients with separate primary objectives in each of in two cohorts: Cohort A: Hematopoeitic stem cell transplantation (HSCT) eligible patients undergoing second-line salvage chemoimmunotherapy \[Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE)\] plus acalabrutinib:. Cohort B: Individuals not eligible for HSCT undergoing second-line salvage chemoimmunotherapy \[Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE)\] plus acalabrutinib followed by acalabrutinib as a maintenance therapy
Timeline
- Start
- 2019-08-16
- Primary completion
- 2023-09
- Completion
- 2023-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acalabrutinib | Small molecule | 100 mg | Oral |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Background | Ifosfamide | Small molecule | 5000 mg/m2 | — |
| Background | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | carmustine | Small molecule | 300 mg/m2 | Intravenous |