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Anti-metabolites

Pacritinib + Azacitidine for Leukemia

Phase 1 & 2

Waitlist Available

Led By Douglas Tremblay, MD

Research Sponsored by Douglas Tremblay

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be JAK inhibitor naïve.

Participants must have a pathologically confirmed diagnosis of chronic myelomonocytic leukemia per World Health Organization (WHO) or International Consensus Classification (ICC).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial tests a drug combo to treat Chronic Myelomonocytic Leukemia (CMML). Patients must have not previously received a JAK inhibitor. Initial dose is 200mg twice daily, with possible escalation to 100mg if needed. 6-12 patients will be enrolled in phase 1, 12 in phase 2. Interim analysis for futility.

Who is the study for?

Adults diagnosed with Chronic Myelomonocytic Leukemia (CMML) who haven't taken JAK inhibitors and have had at most one cycle of hypomethylating agents. They should be in a specific risk category, have a life expectancy over 24 weeks, and an ECOG status ≤3. Participants must not have certain other health conditions or recent treatments that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing pacritinib combined with azacitidine on CMML patients. It starts with phase 1 to find the safest dose level, followed by phase 2 to assess effectiveness using criteria from the MDS/MPN IWG. The treatment involves taking pacritinib twice daily and azacitidine for seven days every four-week cycle.See study design

What are the potential side effects?

Potential side effects include reactions related to blood disorders, digestive issues due to oral intake of pacritinib, increased risk of infections, possible organ inflammation due to immune responses, fatigue from treatment regimens, and complications if there's pre-existing heart or liver conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never taken JAK inhibitor medications.

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My diagnosis is chronic myelomonocytic leukemia, confirmed by a doctor.

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I am 18 years old or older.

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My CMML is either fast-growing or considered intermediate-2/high risk.

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I can take care of myself but spend more than half of my waking hours in bed or a chair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity of Pacritinib in combination with Azacitidine

Overall Response Rate (ORR) to measure clinical benefit

Proportion of participants that achieve clinical benefit or better measured using 2015 MDS/MPN IWG Criteria

Secondary outcome measures

Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score

Change in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SASF TSS)

Change in Palpable Spleen Size

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pacritinib in combination with AzacitidineExperimental Treatment2 Interventions

Participants will take pacritinib 200 mg BID for each 28 day cycle, azacitidine 75mg/m2 will be administered IV or SQ QD D1-7 of each 28 day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pacritinib

2017

Completed Phase 2

~330

Azacitidine

2012

Completed Phase 3

~1440

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Douglas TremblayLead Sponsor

Sobi, Inc.Industry Sponsor

12 Previous Clinical Trials

601 Total Patients Enrolled

Douglas Tremblay, MDPrincipal InvestigatorIcahn School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this exploration?

"As demonstrated on clinicaltrials.gov, the recruitment for this medical trial has ended; it was first posted on February 1st 2024 and had its last update on November 28th 2023. Nevertheless, there are currently 1438 other studies that are actively searching for participants."

Answered by AI

What objectives does this medical investigation hope to accomplish?

"The primary objective of this medical study, to be assessed over a four week period, is to measure the proportion of participants that benefit from clinical care according to 2015 MDS/MPN IWG Criteria. Secondary outcomes include Disease Free Survival (DFS) as an estimation for efficacy and Patient Global Impression of Change (PGIC), which considers self-reported relieving effects on a scale ranging from 0-7 where higher numbers imply greater improvement, in order to evaluate health related quality of life before and after treatment. Additionally, there will also be assessment with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pacritinib in CMML

Douglas Tremblay 2024. "Pacritinib in CMML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06159491.