Open Label Phase 2 Study of Tasquinimod for Patients with Myelofibrosis

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06327100

Provider View

This clinical trial is exploring whether the drug tasquinimod, alone or with another medication called ruxolitinib, can help manage different types of myelofibrosis, a bone marrow disorder.

Patient Parameters

Program Overview

The study aims to find out if tasquinimod, either by itself or combined with ruxolitinib, can effectively control primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocytosis myelofibrosis (post-ET MF). Researchers will measure how well the treatment works by looking at the number of patients who experience complete or partial remission or clinical improvement after six treatment cycles. They will also assess the safety of tasquinimod, the time it takes for patients to respond to the treatment, and how long the response lasts. Additionally, the study will evaluate changes in symptoms, bone marrow condition, and how the body processes tasquinimod. Researchers will also explore if genetic markers affect how patients respond to the treatment.

Description

This study is testing the effectiveness and safety of tasquinimod, a drug that may help treat myelofibrosis, a condition where scar tissue forms in the bone marrow. The study will look at how well tasquinimod works alone and when combined with ruxolitinib, another medication. Researchers will measure the treatment's success by checking how many patients achieve remission or improvement in their condition. They will also monitor any side effects and how long it takes for patients to respond to the treatment. The study will track changes in symptoms and bone marrow health, and analyze how the body absorbs and processes tasquinimod. Additionally, researchers will investigate if certain genetic factors influence the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocytosis myelofibrosis (post-PV/ET MF) that requires treatment.
  • Not suitable for, intolerant of, or have not benefited from approved JAK inhibitors like ruxolitinib.
  • For those on ruxolitinib, must have been on a stable dose for at least 2 months and have a suboptimal response.
  • Must be 18 years or older.
  • Able to swallow pills and willing to follow the study schedule and procedures.
  • Meet specific health criteria, including adequate blood counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study.
  • Men must agree to use effective birth control during the study and for 6 months after.
  • Must provide written informed consent to participate.

Exclusion Criteria

  • Have severe or uncontrolled medical conditions that could increase risk during the study.
  • Have significant heart problems or recent heart attack.
  • Currently taking high doses of steroids or other immunosuppressive treatments.
  • Have had recent chemotherapy or other specific treatments.
  • Have gastrointestinal issues that affect drug absorption.
  • Have active hepatitis or HIV.
  • Have significant infections requiring treatment.
  • Have a history of pancreatitis or malabsorption.
  • Taking certain medications that interact with the study drug.
  • Pregnant or breastfeeding women.
  • Known allergy to tasquinimod or its ingredients.
  • Any condition that the study doctor believes would make participation unsafe.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.