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New treatment option for Myeloproliferative Neoplasm
Official title Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms
ClinicalTrials.gov ID: NCT05074355
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, being studied as a potential treatment for myeloproliferative neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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 treatment 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.
See the full eligibility 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.