Actively Recruiting
Tasquinimod in Patients with Myelofibrosis Refractory to or Intolerant for JAK2 Inhibition
Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2025-03-07
20
Participants Needed
6
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if therapy can be improved in patients with myelofibrosis (MF) who have primary resistance or who have progressed after treatment with a Janus kinase (JAK) inhibitor or are intolerant for this category of drugs. The main questions it aims to answer are: * To evaluate the feasibility and safety of once daily dose of tasquinimod for 24 weeks (6 cycles) * To determine the optimal dose Patients will be treated once daily with tasquinimod for a maximum period of 24 weeks (6 cycles). During the study most (diagnostic) procedures are part of the standard of care. Different from standard of care: * Participation may lead to extra visits to the outpatient clinic * Additional blood will be drawn when blood is already taken per standard of care * Bone marrow sampling at entry and at the end of the trial * MRI scans (or CT-scans) have to be performed * Quality-of-life questionnaires have to be filled out
CONDITIONS
Official Title
Tasquinimod in Patients with Myelofibrosis Refractory to or Intolerant for JAK2 Inhibition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary myelofibrosis or post-polycythemia vera or post-essential thrombocythemia myelofibrosis based on a bone marrow biopsy less than 6 months old according to 2016 WHO criteria
- Refractory or intolerant to approved Janus kinase inhibitor treatment or ineligible for JAK inhibitor treatment
- Myelofibrosis classified as Intermediate-1 with symptoms, Intermediate-2, or high-risk by Dynamic International Prognostic Scoring System Plus
- Spleen size at least 5 cm below the costal margin measured by palpation
- Age 18 years or older
- Peripheral blood blast count less than 10%
- WHO/ECOG performance status 0, 1, or 2
- Able to swallow and keep oral medication
- Willing and able to follow scheduled visits, treatment plan, and lab tests
- Negative pregnancy test at study start for women of childbearing potential
- Women of childbearing potential and sexually active men must agree to use effective contraception during treatment and for 4 months (women) or 6 months (men) after treatment
- Capable of giving informed consent
- Provided written informed consent
You will not qualify if you...
- Eligible for hematopoietic stem cell transplantation with a suitable donor available
- Previous splenectomy
- Splenic irradiation within the last 6 months
- Prior allogeneic stem cell transplantation
- Laboratory values within 14 days before registration: ANC less than 0.5 x 10^9/L without G-CSF support, platelet count less than 25 x 10^9/L without transfusion, serum creatinine above 1.5 times upper limit of normal or GFR less than 30 ml/min, serum amylase and lipase above 1.5 times upper limit of normal, ALT greater or equal to 2.5 times upper limit of normal, total bilirubin above 1.5 times upper limit unless due to Gilbert's syndrome or related to MF
- Active hepatitis A, B, or C infection or carriers; HIV infection
- History of chronic liver disease such as alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, or hemochromatosis
- Prior cancers except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancers disease-free for at least 5 years
- Not fully recovered from significant side effects of prior chemotherapy
- Gastrointestinal diseases affecting tasquinimod absorption
- Severe or uncontrolled cardiovascular conditions within 6 months prior
- Active infections requiring therapy
- Recent chemotherapy, immunomodulatory drugs, corticosteroids above 10 mg/day prednisone equivalent, or growth factor treatments within specified time frames
- Treatment with fedratinib or momelotinib within specific days before study
- Investigational treatment for MF within 2 weeks or 5 half-lives
- Severe allergic reaction to tasquinimod components
- Recent use of strong CYP3A4 inhibitors or inducers
- Need for ongoing therapy with drugs metabolized mainly by CYP3A4 or CYP1A2
- Ongoing treatment with vitamin K antagonists unless INR is 3.0 or less
- Prior treatment with tasquinimod
- Major surgery within 3 months
- Pregnant or breastfeeding
- Other conditions preventing safe participation or compliance
- Current participation in another interventional clinical trial
- Psychological, family, social, or geographic conditions that may affect study compliance
AI-Screening
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Trial Site Locations
Total: 6 locations
1
DE-Aachen-UKAACHEN
Aachen, Germany
Not Yet Recruiting
2
NL-Amsterdam-AmsterdamUMC
Amsterdam, Netherlands
Not Yet Recruiting
3
NL-Groningen-UMCG
Groningen, Netherlands
Not Yet Recruiting
4
NL-Nijmegen-RADBOUDUMC
Nijmegen, Netherlands
Actively Recruiting
5
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
Not Yet Recruiting
6
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
Not Yet Recruiting
Research Team
P
Peter te Boekhorst, Dr.
CONTACT
M
Martina Chrysandt, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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