Tasquinimod for Myelofibrosis

Phase 2

Recruiting

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Ruxolitinib

2018

Completed Phase 3

~1170

Tasquinimod

2012

Completed Phase 2

~210