New drug duo aims to halt deadly blood cancer progression
NCT ID NCT05074355
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tests whether combining two drugs, venetoclax and azacitidine, is safe and effective for people with a rare, advanced blood cancer called myeloproliferative neoplasm (MPN) that has worsened. About 40 participants will receive the combination therapy. The goal is to see if the treatment can bring the cancer back to a less aggressive stage or achieve remission.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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- Can a modified interferon rein in early myelofibrosis?