Pacritinib + Venetoclax + Azacitidine for Myeloproliferative Neoplasms
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of drugs—pacritinib, venetoclax, and azacitidine—to determine the optimal dose and assess side effects in treating advanced-stage myeloproliferative neoplasms, a type of blood cancer. The goal is to evaluate whether these drugs can safely and effectively inhibit cancer cell growth. Individuals with a previous diagnosis of certain blood disorders, now in an advanced stage, may be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research is examining the effectiveness and optimal dosing of a combination of three drugs: pacritinib, venetoclax, and azacitidine. Earlier studies showed that pacritinib with azacitidine might be safe and manageable for patients. Venetoclax with azacitidine carries some risks, such as reducing blood cell production, but also shows promise in treating certain blood cancers.
In this trial's early stages, researchers focus on safety and determining the right dose. This phase assesses how well patients tolerate the treatment and identifies any side effects. While there is potential, the safety of this combination remains under study.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Pacritinib, Venetoclax, and Azacitidine because it targets myeloproliferative neoplasms in a unique way. Unlike traditional treatments that may focus on one pathway, this combination targets multiple pathways involved in cancer cell growth and survival. Pacritinib is a selective kinase inhibitor, Venetoclax disrupts proteins that prevent cancer cell death, and Azacitidine affects DNA methylation. This multi-pronged approach has the potential to be more effective and may overcome resistance seen with single-agent therapies.
What evidence suggests that this trial's treatments could be effective for myeloproliferative neoplasms?
Research has shown that the combination of pacritinib, venetoclax, and azacitidine, which participants in this trial will receive, may effectively treat advanced stages of myeloproliferative neoplasms, a type of blood cancer. Studies have found that using azacitidine and venetoclax together can lead to a 77% overall response rate, with 42% of patients experiencing complete remission. Additionally, pacritinib and azacitidine may stop cancer cells from growing by blocking the enzymes they need. This combination has also proven effective and well-tolerated in patients with different genetic types of acute myeloid leukemia (AML). These findings suggest that the treatment might work for similar conditions, such as accelerated and blast phase myeloproliferative neoplasms.12678
Who Is on the Research Team?
Steven Green, MD
Principal Investigator
Roswell Park Comprehensive Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with accelerated or blast phase myeloproliferative neoplasms (a type of blood cancer). Participants should be able to undergo treatment and tests, but specific inclusion and exclusion criteria are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pacritinib, venetoclax, and azacitidine in cycles of 28 days for up to 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Pacritinib
- Venetoclax
Trial Overview
Researchers are testing the safety and best dose of pacritinib when combined with venetoclax and azacitidine in people with advanced myeloproliferative neoplasms. The study uses imaging scans and bone marrow tests to monitor effects.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Pacritinib in combination with venetoclax and azacitidne. Dose will increase until side effects occur or maximum tolerated dose is reached. Additionally, patients undergo MRI or CT as well as bone marrow aspiration and biopsy throughout the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
Citations
Phase I Trial of Pacritinib in Combination With Venetoclax ...
Pacritinib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Venetoclax with azacitidine or decitabine in blast‐phase ...
Although overall median survival was only 3.6 months, the 3‐year survival rate was significantly higher (32%) among 24 patients who received allogeneic ...
3.
targetedonc.com
targetedonc.com/view/azacitidine-venetoclax-ruxolitinib-shows-encouraging-responses-in-mpnsAzacitidine, Venetoclax, Ruxolitinib Shows Encouraging ...
The overall response rate was 80%, and the complete remission (CR) rate was 40%. The median overall survival was 13.4 months (95% CI, 4.2-13.4), ...
4.
trialscreen.org
trialscreen.org/trials/phase-1-pacritinib-combination-venetoclax-azacitidine-treatment-accelerated-trial-nct07679334Phase I Trial of Pacritinib in Combination With Venetoclax ...
Pacritinib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Dr Marvin-Peek on the Significance of Efficacy Data ...
Among evaluable patients in the trial (n = 40), overall response rates (ORR) with azacitidine, plus venetoclax and ivosidenib was 95%. Moreover, ...
6.
hematologyadvisor.com
hematologyadvisor.com/news/aml-venetoclax-azacitidine-chemotherapy-ineligible-patients-may-benefit/Chemotherapy-Ineligible Patients With AML May Benefit ...
The median overall survival period was 14.7 months in the venetoclax plus azacitidine cohort vs 9.6 months with placebo plus azacitidine.
7.
ashpublications.org
ashpublications.org/bloodadvances/article/5/8/2156/475773/Single-center-experience-with-venetoclaxSingle-center experience with venetoclax combinations in ...
Venetoclax-based therapy was associated with significant myelosuppression and mortality, with a median survival of 4 months.
Pacritinib, Venetoclax, and Azacitidine Combination for ...
This study aims to determine the maximum tolerated dose of a treatment regimen combining Pacritinib, Venetoclax, and Azacitidine for individuals
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