Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05074355

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

Led by University Health Network, Toronto · Updated on 2025-12-18

40

Participants Needed

1

Research Sites

164 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to voluntarily provide written informed consent
  • Diagnosis of BCR-ABL negative myeloproliferative neoplasms according to WHO 2016 criteria
  • Disease transformed to accelerated phase or blast phase without prior blast reduction therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate organ function
  • Use of at least one reliable birth-control method from study start to 90 days after last dose
  • Negative serum pregnancy test within 14 days before starting treatment for females of childbearing potential
Not Eligible

You will not qualify if you...

  • History of allogeneic stem cell transplant for myeloproliferative neoplasm
  • Previous treatment with venetoclax, navitoclax, azacitidine, or other hypomethylating agents
  • White blood cell count greater than 25 x 10^9/L
  • Currently enrolled in another interventional study
  • Active uncontrolled infection despite treatment
  • Myocardial infarction within past 3 months
  • Active HIV, hepatitis B, or hepatitis C infection
  • History of active malignancy within past 2 years
  • Psychiatric illness, social circumstances, or co-morbid conditions compromising participation
  • Pregnant or breastfeeding women
  • Central nervous system involvement with acute myeloid leukemia or extramedullary hematopoiesis
  • Presence of t (15;17) chromosomal abnormality
  • Use of strong or moderate CYP3A inducers within 7 days before treatment
  • Active COVID-19 infection
  • Prior blast-reduction therapy for accelerated or blast phase myeloproliferative neoplasm
  • History of myelodysplastic syndromes or overlap syndromes such as MDS or CMML

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

V

Vikas Gupta, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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