NCT05074355 Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms
| NCT ID | NCT05074355 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Health Network, Toronto |
| Condition | Myeloproliferative Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-11-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2023-11-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Vikas Gupta, M.D.
PRINCIPAL INVESTIGATOR
Princess Margaret Cancer Centre
Frequently Asked Questions
Who can join the NCT05074355 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloproliferative Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05074355 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05074355 currently recruiting?
Yes, NCT05074355 is actively recruiting participants. Contact the research team at vikas.gupta@uhn.ca for enrollment information.
Where is the NCT05074355 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05074355 clinical trial?
NCT05074355 is sponsored by University Health Network, Toronto. The principal investigator is Vikas Gupta, M.D. at Princess Margaret Cancer Centre. The trial plans to enroll 40 participants.