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Taking people in CanadaPhase 2

Tests venetoclax with azacitidine in advanced myeloproliferative neoplasms

Tests venetoclax and azacitidine together in adults with advanced myeloproliferative neoplasms.

Plain-language title generated from the registry record
Registry title: Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms

Key facts

Where
Toronto, CanadaSee the site
Phase
Phase 2

Where in Canada

  • Princess Margaret Cancer CentreToronto, CanadaTaking people

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  4. What happens if I want to stop?
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Trial details

Who runs it
University Health Network, Toronto
Trial code
NCT05074355
Record updated
6 July 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Previous treatment with venetoclax, navitoclax, azacytidine or other hypomethylating agents (HMA); History of active malignancy in the previous 2 years; Patients who have received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment; History of prior blast-reduction therapy for AP/BP-MPN; History of allogeneic stem cell transplant for MPN; 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; Any psychiatric illness or social circumstances or significant co-morbid conditions that may compromise study participation; Active COVID-19 infection; Preceding history MDS, chronic myelomonocytic leukemia (CMML), and other myelodysplastic syndromes (MDS)/MPN overlap syndromes; White blood cell count >25 x 10\^9/L; Current enrollment in another interventional study; 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).

ClinicalTrials.gov NCT05074355