About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Azacitidine
DrugAzacitidine is a hypomethylating agent that works by activating certain genes in the body to help cells mature and to kill abnormal bone marrow cells.
Venetoclax
DrugVenetoclax is a drug that blocks a protein called B-cell lymphoma (BCL2) protein from working. BCL2 is a protein that helps control whether a cell lives or dies and is thought to help cancer cells to live. Blocking BCL2 is believed to help kill cancer cells.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of participants achieving complete remission (CR).
Proportion of participants achieving complete remission with incomplete hematologic recovery (CRi).
Proportion of participants achieving reversion to chronic myeloproliferative neoplasm (CMPN).
Secondary outcomes
Average number of days from the first dose of azacytidine and venetoclax to the date of death.
Average number of days from CR until relapse.
Average number of days from CRi until relapse.
Average number of days from CMPN until relapse.
Sponsors and contacts
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