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.
All participants in this study will receive azacitidine and venetoclax. This study will be done in multiple stages: Safety Run-In Period - 7 participants will receive the study drugs to ensure that the combination is safe and tolerable. Stage 1 - About 15 participants will receive the study drugs and will be evaluated to see whether they respond to the study drugs. Stage 2 - If enough participants in Stage 1 respond to the study drugs, then Stage 2 will begin. During this stage, an additional 25 participants will take part in the study to further see if participants respond to the study drugs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Azacitidine 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 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.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGProportion of participants achieving complete remission (CR).
Time frame: 3 years
Proportion of participants achieving complete remission with incomplete hematologic recovery (CRi).
Time frame: 3 years
Proportion of participants achieving reversion to chronic myeloproliferative neoplasm (CMPN).
Time frame: 3 years
Average number of days from the first dose of azacytidine and venetoclax to the date of death.
Time frame: 3 years
Average number of days from CR until relapse.
Time frame: 3 years
Average number of days from CRi until relapse.
Time frame: 3 years
Average number of days from CMPN until relapse.
Time frame: 3 years
The proportion of patients proceeding to allogeneic stem cell transplantation in those eligible for transplantation.
Time frame: 3 years
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