drugset / Trial / NCT03623373
Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
This study is designed to evaluate the efficacy and safety of acalabrutinib plus bendamustine and rituximab followed by acalabrutinib plus cytarabine and rituximab in subjects with treatment naïve mantle cell lymphoma (MCL), as a preparation for a larger cooperative group trial with the goal of achieving a standard induction regimen for MCL in transplant eligible patients. The investigators hypothesize that the addition of acalabrutinib to BR/CR regimen will prove safe and increase the complete response (CR) rate as well as minimal residual disease (MRD) negativity pre-transplant, thus improving clinical outcomes.
Timeline
- Start
- 2018-11-29
- Primary completion
- 2020-02-09
- Completion
- 2025-04-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acalabrutinib | Small molecule | — | Oral |
| Background | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |