Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Azacitidine

    Drug

    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

    Drug

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Azacitidine and VenetoclaxExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants achieving complete remission (CR).

Time frame
3 years
2

Proportion of participants achieving complete remission with incomplete hematologic recovery (CRi).

Time frame
3 years
3

Proportion of participants achieving reversion to chronic myeloproliferative neoplasm (CMPN).

Time frame
3 years

Secondary outcomes

1

Average number of days from the first dose of azacytidine and venetoclax to the date of death.

Time frame
3 years
2

Average number of days from CR until relapse.

Time frame
3 years
3

Average number of days from CRi until relapse.

Time frame
3 years
4

Average number of days from CMPN until relapse.

Time frame
3 years

Other outcomes

Sponsors and contacts

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