NCT05074355RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 29 Sept 2021
- Start date
- 8 Nov 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT05074355
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 8 Nov 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- White blood cell count \>25 x 10\^9/L.
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.