Venetoclax and Azacitidine Combination Therapy for Patients With Accelerated or Blast Phase BCR-ABL Negative Myeloproliferative Neoplasm (VAAMP)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Vikas Gupta, M.D.
vikas.gupta@uhn.ca
416-946-2885
Time Frame
Start Date: 2023-11-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Azacitidine and Venetoclax
A treatment cycle is 28 days long.~Azacitidine will be given by injection under the skin, once a day, for the first 6 days of every cycle.~Venetoclax will be given orally, once a day, as follows at the discretion of their study doctors:~Cycle 1:~* Day 1 - 100 mg~* Day 2 - 200 mg~* Days 3 to 28 - 400 mg~Cycle 2:~* Participants with a response to the study drugs will continue taking 400 mg from Days 1 to 21, with no study drug from Days 22 to 28 during Cycle 2.~* Participants who have not yet responded to the study drugs will continue taking 400 mg from Days 1 to 28 during Cycle 2.~Cycle 3 and subsequent cycles:~* Participants with a response to the study drugs will continue to take 400 mg from Days 1 to 21, with no study drug from Days 22 to 28.~* Participants whose disease has not worsened will continue taking 400 mg from Days 1 to 28.~* Participants have not responded to the study drugs will be withdrawn from the study.
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov

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