drugset / Trial / NCT06524375
A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period
NaSingle-groupOpen-labelTreatment
Summary
The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease \[uMRD \< or 10\^-4 in peripheral blood (PB)\] by end of combination treatment (EOCT) to allow off-treatment period. The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.
Timeline
- Start
- 2024-08-09
- Primary completion
- 2026-10-31
- Completion
- 2030-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Background | Acalabrutinib | Small molecule | — | — |
| Background | Ibrutinib | Small molecule | — | — |
| Background | Zanubrutinib | Small molecule | — | — |