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

• Status: Not yet recruiting
• Trial end date: 2024-12-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Azacitidine; Venetoclax

Criteria

Inclusion Criteria:

• Ability to voluntarily provide written informed consent.

• Documented diagnosis per World Health Organization (WHO) 2016 criteria of BCR-ABL negative myeloproliferative neoplasms (MPN).

• Documented MPN transformation to accelerated phase (AP) or blast phase (BP) without prior blast reduction therapy for their AP/BP disease.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Adequate organ function.

• Must practice at least one reliable method of birth-control starting at least on cycle 1 day 1 until at least 90 days after the last dose of study drug.

• Female participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1.

Exclusion Criteria:

• History of allogeneic stem cell transplant for MPN.

• Previous treatment with venetoclax, navitoclax, azacytidine or other hypomethylating agents (HMA).

• White blood cell count >25 x 10^9/L.

• Current enrollment in another interventional study.

• Presence of any active uncontrolled infection such as bacterial or fungal infections progressing despite adequate antimicrobial treatment.

• Myocardial infarction in the preceding 3 months.

• Active human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) infection.

• History of active malignancy in the previous 2 years.

• Any psychiatric illness or social circumstances or significant co-morbid conditions that may compromise study participation.

• Pregnant or breastfeeding women.

• Patients with known central nervous system (CNS) involvement with acute myeloid leukemia (AML) or CNS extramedullary hematopoiesis.

• Patients with t (15;17)

• Patients who have received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment.

• Active COVID-19 infection.

• History of prior blast-reduction therapy for AP/BP-MPN.

• Preceding history MDS, chronic myelomonocytic leukemia (CMML), and other myelodysplastic syndromes (MDS)/MPN overlap syndromes.