drugset / Trial / NCT02781883
Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.
Timeline
- Start
- 2016-05
- Primary completion
- 2027-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PREXIGEBERSEN | Antisense oligonucleotide | — | — |
| Subject | Venetoclax | Small molecule | — | — |
| Background | Decitabine | Small molecule | — | — |