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JAK Inhibitor

Group 1 for Primary Myelofibrosis

Phase 2

Waitlist Available

Led By Lucia Masarova, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

"This trial aims to see if tasquinimod, on its own or when combined with ruxolitinib, can help manage certain types of myelofibrosis."

Who is the study for?

This trial is for patients with certain types of bone marrow disorders: Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF). Specific eligibility criteria are not provided, but typically include factors like age, disease stage, and overall health.Check my eligibility

What is being tested?

The study is testing the effectiveness of a drug called Tasquinimod alone or combined with another medication named Ruxolitinib in controlling PMF, post-PV MF, or post-ET MF. It's an open-label phase 2 study which means everyone knows what treatment they're getting.See study design

What are the potential side effects?

While specific side effects are not listed here, drugs like Tasquinimod and Ruxolitinib can commonly cause issues such as fatigue, liver function changes, digestive disturbances and may affect blood counts leading to increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety and adverse events (AEs)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment2 Interventions

Participants who are already on a stable dose of ruxolitinib for at least 8 weeks who have achieved a sub-optimal response will be assigned to Group 2. In Group 2, participants will receive tasquinimod daily on days 1-28 and ruxolitinib dose will be continued.

Group II: Group 1Experimental Treatment1 Intervention

Participants have already been receiving ruxolitinib for at least 3 months and are not responding well to ruxolitinib or have low blood cell counts, participants will be assigned to Group 1. In Group 1, participants will receive tasquinimod alone daily each 28 day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tasquinimod

2012

Completed Phase 2

~210

Ruxolitinib

2018

Completed Phase 3

~1140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,486 Total Patients Enrolled

26 Trials studying Primary Myelofibrosis

879 Patients Enrolled for Primary Myelofibrosis

Active Biotech ABIndustry Sponsor

11 Previous Clinical Trials

2,152 Total Patients Enrolled

Lucia Masarova, MDPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

240 Total Patients Enrolled

Frequently Asked Questions

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

Has Group 2 received FDA authorization?

"Based on our evaluation, Group 2 has been assigned a safety rating of 2 out of 3. This assessment is due to the absence of efficacy data, though there exists preliminary safety information in this Phase 2 study."

Answered by AI

Are potential candidates able to apply for participation in this ongoing trial?

"As detailed on clinicaltrials.gov, this particular study is no longer actively seeking participants. Originally posted on March 13th, 2024 and last updated on March 15th, 2024. Despite its closure for enrollment, there are currently 113 alternative trials open to recruiting new subjects presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open Label Phase 2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)

2024. "Open Label Phase 2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06327100.

All > Essential Thrombocythemia > Polycythemia Vera