Actively Recruiting
Open Label Phase 1/2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)
Led by M.D. Anderson Cancer Center · Updated on 2026-02-27
33
Participants Needed
1
Research Sites
352 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Active Biotech AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF.
CONDITIONS
Official Title
Open Label Phase 1/2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with treatment-requiring primary myelofibrosis or post-ET/PV myelofibrosis with intermediate-1, intermediate-2, or high-risk disease, or low-risk with symptomatic splenomegaly 5 cm below the left costal margin
- Peripheral or bone marrow blasts less than 10%
- Age 18 years or older
- Able to swallow and retain oral medication
- ECOG performance status 0-2
- Absolute neutrophil count 1.0 x 10^9/L (1000/mm3)
- Serum direct bilirubin less than or equal to 1.0 times the upper limit of normal
- AST or ALT less than or equal to 2.5 times the upper limit of normal (up to 5 times if liver involved)
- Glomerular filtration rate 30 ml/min
- Prior JAK inhibitor therapy not required; monotherapy group includes those not candidates for or intolerant of JAK inhibitors
- For combination group, treated with stable dose of ruxolitinib for at least 3 months with suboptimal response
- Resolved prior treatment toxicities to grade 1
- At least 2 weeks since prior investigational myelofibrosis treatment (except concurrent ruxolitinib allowed in combination group)
- Hydroxyurea allowed up to one day before starting tasquinimod
- Women of childbearing potential must have a negative pregnancy test and agree to use adequate contraception
- Men must agree to use adequate contraception before, during, and for 6 months after treatment
- Able and willing to comply with study visits, treatment plan, and lab tests
- Provide written informed consent
You will not qualify if you...
- Severe or uncontrolled medical conditions increasing risk or confounding safety assessments
- Significant cardiac diseases including ventricular tachyarrhythmia, unstable atrial fibrillation, resting bradycardia below 50 bpm, recent angina or heart attack within 3 months, or other serious heart conditions
- Chronic corticosteroid use at doses 10 mg prednisone per day or other immunosuppressive treatments that cannot be stopped
- Chemotherapy, immunomodulatory, or erythropoietin treatment within 28 days before study treatment
- Experimental therapy within past 2 weeks or 5 half-lives, whichever is shorter
- Prior treatment with tasquinimod
- Gastrointestinal diseases or impairments affecting drug absorption
- Known or active hepatitis A, B, C, or HIV infection
- Clinically significant infections requiring therapy
- History of pancreatitis
- Malabsorption or conditions interfering with drug absorption
- Recent use of certain drugs that strongly affect cytochrome P-3A4, P-1A2, or P-2D6 enzymes
- Current warfarin treatment unless INR 3.0
- Known allergy to tasquinimod or its components
- Pregnancy or breastfeeding
- Any other condition judged by the investigator to prevent safe participation or adherence
- Prior participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Lucia Masarova, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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