NCT05074355

Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms

Venetoclax and Azacitidine Combination Therapy for Patients With Accelerated or Blast Phase BCR-ABL Negative Myeloproliferative Neoplasm (VAAMP)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to look at how safe and useful a drug called azacitidine in combination with a drug called venetoclax, is in people with accelerated or blast phase BRC-ABL negative myeloproliferative neoplasms.

Detailed description

All participants in this study will receive azacitidine and venetoclax. This study will be done in multiple stages: Safety Run-In Period - 7 participants will receive the study drugs to ensure that the combination is safe and tolerable. Stage 1 - About 15 participants will receive the study drugs and will be evaluated to see whether they respond to the study drugs. Stage 2 - If enough participants in Stage 1 respond to the study drugs, then Stage 2 will begin. During this stage, an additional 25 participants will take part in the study to further see if participants respond to the study drugs.

Conditions

• Myeloproliferative Neoplasm

Interventions

Type	Name	Description
DRUG	Azacitidine	Azacitidine is a hypomethylating agent that works by activating certain genes in the body to help cells mature and to kill abnormal bone marrow cells.
DRUG	Venetoclax	Venetoclax is a drug that blocks a protein called B-cell lymphoma (BCL2) protein from working. BCL2 is a protein that helps control whether a cell lives or dies and is thought to help cancer cells to live. Blocking BCL2 is believed to help kill cancer cells.

Timeline

• Start date: 2023-11-08
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-10-12
• Last updated: 2025-12-18

Locations

1 site across 1 country: Canada