MyelofibrosisPhase 1/2HOVON 172 MFNCT06605586
Tasquinimod in Patients with Myelofibrosis Refractory to or Intolerant for JAK2 Inhibition
A Phase 1/2 study testing Tasquinimod in people with Myelofibrosis, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- Tasquinimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 20 Feb 2025to Mar 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PMF or Post-PV MF or Post-ET MF based on a bone marrow (BM) biopsy not older than 6 months, according to the 2016 World Health Organization.
- Refactory or intolerant to treatment with an approved JAK inhibitor or ineligible for JAK inhibitor treatment.
- MF classified as Intermediate-1 with disease-related symptoms (e.g. symptomatic splenomegaly), Intermediate-2 or high-risk by Dynamic International Prognostic Scoring System Plus
- Spleen ≥5 cm below costal margin as measured by palpation.
- Age ≥18 years.
- Peripheral blood blast count of <10%.
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- WHO/ECOG performance status of 0, 1, or 2.
- Able to swallow and retain oral medication.
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
- Negative pregnancy test at study entry for women of childbearing potential. Women of child-bearing potential and sexually active males must be willing and able to use highly effective methods of contraception, during treatment, and for 4 months and 6 months respectively, after study treatment.
- Patient is capable of giving informed consent.
- Written informed consent.
Who cannot join
- Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available).
- Splenectomy.
- Splenic irradiation within the last 6 months.
- Prior allogeneic stem cell transplantation.
- Following laboratory values within 14 days prior to registration:
- Absolute Neutrophil Count (ANC) <0.5 x 109/L without G-CSF support
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- Platelet count <25 x 109/L without platelet transfusion
- Serum creatinine >1.5 x Upper limit of normal (ULN) or GFR <30 ml/min
- Serum amylase and lipase >1.5 x ULN
- Alanine aminotransferase (ALT) ≥2.5 x ULN
- Total bilirubin >1.5 times the upper limit of the normal range (ULN), unless elevated bilirubin is due to unconjugated hyperbilirubinemia from Gilbert's syndrome or related to MF
- Known active (acute or chronic) Hepatitis A, B, or C; and Hepatitis B and C carriers, HIV.
- Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis).
- Patients with any other prior malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 5 years.
- Failure to have fully recovered (i.e. to CTCAE Grade 1 or previous baseline) from clinically significant adverse effects of prior chemotherapy (examples of adverse effects that are not clinically significant include alopecia and lymphopenia).
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of tasquinimod (e.g., ulcerative diseases, pancreatitis uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
- Evidence of severe or currently uncontrolled cardiovascular condition (e.g. cardiac amyloidosis, pulmonary embolism, angina, hypertension, peripheral vascular disease, congestive heart failure class III or IV of the NYHA classification (appendix F), cardiac arrhythmia, acute coronary syndrome, myocardial infarction, cerebrovascular accident, major hemorrhage, intracranial hemorrhage, transient ischemic attack, or limb claudication) within 6 months prior to registration.
- Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/ enrollment until the course of antibiotic therapy has been completed.
- Any chemotherapy, immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 2 weeks prior to initiation of tasquinimod; erythropoetin use within 28 days prior to initiation of tasquinimod. The only chemotherapy allowed will be hydroxyurea which has to be stopped within 1 day prior to initiation of tasquinimod.
- Treatment with fedratinib within 7 days, or momelotinib within 2 days prior to initiation of tasquinimod. For ruxolitinib no wash-out period is required before start of tasquinimod.
- Any investigational treatment for MF within 2 weeks or 5 half-lives whichever is shorter.
- History of severe hypersensitivity reaction to any component of tasquinimod.
- Systemic treatment within 14 days prior to the initiation of tasquinimod with any of the moderate or strong inhibitor, or moderate or strong inducer of cytochrome P-3A4 (CYP3A4)
- Need for ongoing therapy with drug substances of narrow therapeutic range that are metabolized mainly by CYP3A4
- Need for ongoing therapy with drug substances of narrow therapeutic range metabolized mainly by CYP1A2
- Ongoing treatment with vitamin K antagonist, unless the INR is ≤ 3.0
- Prior treatment with tasquinimod.
- Major surgery within 3 months.
- Pregnant or breast feeding (lactating) women.
- Any other condition that would, in the Investigator's judgment, contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures e.g. any uncontrolled disease such as pulmonary disease, infection or seizure disorder; intestinal obstruction, inability to swallow medication, any altered mental status or psychiatric condition that would interfere with the understanding of the informed consent
- Current participation (during interventional treatment) in another clinical trial.
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Netherlands5 sites, 5 recruiting
- Not yet recruiting
NL-Amsterdam-AmsterdamUMC
Amsterdam
- Not yet recruiting
NL-Groningen-UMCG
Groningen
- Recruiting
NL-Nijmegen-RADBOUDUMC
Nijmegen
M. Roeven, MD, ho172@erasmusmc.nl
- Not yet recruiting
NL-Rotterdam-ERASMUSMC
Rotterdam
- Not yet recruiting
NL-Utrecht-UMCUTRECHT
Utrecht
Germany1 site, 1 recruiting
- Not yet recruiting
DE-Aachen-UKAACHEN
Aachen
Martine Chrysandt, Dr.
About this study
Official title: A Phase 1b/2 Trial with Tasquinimod in Patients with Myelofibrosis (primary, Post-PV or PostET) Refractory to or Intolerant for JAK2 Inhibition: the TasqForce Trial
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:
Read more
- 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
- Myelofibrosis
- Being tested
- Tasquinimod
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasquinimodDrug
treatment with tasquinimod capsules once daily
| Study group | Role | What they receive |
|---|---|---|
| Tasquinimod | Experimental | Patients will be treated with tasquinimod capsules 0.5 mg/day for 14 days (half cycle) and then capsules of 1 mg/day for the remaining 14 days in the first cycle. In consecutive 28-day cycles 1 mg/day (or if 1 mg/day is not tolerated, reduction to 0.75 or 0.5 mg/day is allowed, followed by dose re-escalation whenever possible). Patients will be treated for a maximum period of 24 weeks (6 cycles). Receives: Drug: Tasquinimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR35W24
Proportion of patients with at least 35% reduction in spleen volume from baseline at Week 24 (SVR35W24) as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan, per International Working Group (IWG) criteria, based on MRI review.
Measured: 24 weeks after start treatment
DLT phase I
To determine the dose limiting toxicity (DLT) of tasquinimod. Pre-defined adverse events (AEs) that occur within 28 days of the start of study treatment will be considered a DLT, unless the AE is definitely unrelated to tasquinimod.
Measured: From enrollment until 28 days after start treatment
Secondary outcomes (9)
RBC transfusions
Red blood cell (RBC) transfusion (number of packed cells) during tasquinimod treatment.
Measured: Until end of protocol treatment after 24 weeks
Changes in variant allele frequency
To determine the changes in variant allele frequency (VAF) of MPN driver genes after tasquinimod treatment by single cell and bulk DNA sequencing.
Measured: Until end of protocol treatment after 24 weeks
Change in splenomegaly
Proportion of patients with at least 50% reduction in palpable splenomegaly from baseline per IWG criteria.
Measured: Until end of protocol treatment after 24 weeks
Change in spleen volume by MRI review
Proportion of patients with at least 35% reduction in spleen volume from baseline (SVR35) as measured by MRI or CT scan, per IWG criteria, based on MRI review.
Measured: Until end of protocol treatment after 24 weeks
Changes of total symptom score
Proportion of patients with at least 50% reduction in total symptom score (TSS) after 24 weeks from baseline as measured by MPN-SAF TSS.
Measured: Until end of protocol treatment after 24 weeks
Changes in bone marrow fibrosis
Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system.
Measured: Until end of protocol treatment after 24 weeks
Safety
Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: until 30 days following the last dose of tasquinimod as protocol treatment
Overall survival
Overall survival, as defined from date of registration until date of death from any cause.
Measured: Until 3 years after enrollment
Anemia response
Anemia response based on transfusion dependency per IWG criteria for MF
Measured: Until end of protocol treatment after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start20 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter te Boekhorst, Dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605586
- Sponsor's protocol ID
- HO172
- Other IDs
- 2024-511565-11-00
- Acronym
- HOVON 172 MF
- Status last verified
- Mar 2025
- First submitted
- 1 Jul 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Trial with Tasquinimod in Patients with Myelofibrosis (primary, Post-PV or PostET) Refractory to or Intolerant for JAK2 Inhibition: the TasqForce Trial
- ClinicalTrials.gov ID
- NCT06605586
- Acronym / sponsor ID
- HOVON 172 MF / HO172
- Conditions
- Myelofibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen NederlandUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tasquinimod | Experimental | Drug: TasquinimodPatients will be treated with tasquinimod capsules 0.5 mg/day for 14 days (half cycle) and then capsules of 1 mg/day for the remaining 14 days in the first cycle. In consecutive 28-day cycles 1 mg/day (or if 1 mg/day is not tolerated, reduction to 0.75 or 0.5 mg/day is allowed, followed by dose re-escalation whenever possible). Patients will be treated for a maximum period of 24 weeks (6 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of PMF or Post-PV MF or Post-ET MF based on a bone marrow (BM) biopsy not older than 6 months, according to the 2016 World Health Organization.
- Refactory or intolerant to treatment with an approved JAK inhibitor or ineligible for JAK inhibitor treatment.
- MF classified as Intermediate-1 with disease-related symptoms (e.g. symptomatic splenomegaly), Intermediate-2 or high-risk by Dynamic International Prognostic Scoring System Plus
- Spleen ≥5 cm below costal margin as measured by palpation.
- Age ≥18 years.
Key exclusion criteria (32 listed)
- Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available).
- Splenectomy.
- Splenic irradiation within the last 6 months.
- Prior allogeneic stem cell transplantation.
- Following laboratory values within 14 days prior to registration:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tasquinimodtreatment with tasquinimod capsules once daily | Drug | Tasquinimod |
Primary outcome
SVR35W24
Time frame: 24 weeks after start treatment
Proportion of patients with at least 35% reduction in spleen volume from baseline at Week 24 (SVR35W24) as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan, per International Working Group (IWG) criteria, based on MRI review.
DLT phase I
Time frame: From enrollment until 28 days after start treatment
To determine the dose limiting toxicity (DLT) of tasquinimod. Pre-defined adverse events (AEs) that occur within 28 days of the start of study treatment will be considered a DLT, unless the AE is definitely unrelated to tasquinimod.
9 secondary outcomes
RBC transfusions
Time frame: Until end of protocol treatment after 24 weeks
Changes in variant allele frequency
Time frame: Until end of protocol treatment after 24 weeks
Change in splenomegaly
Time frame: Until end of protocol treatment after 24 weeks
Change in spleen volume by MRI review
Time frame: Until end of protocol treatment after 24 weeks
Changes of total symptom score
Time frame: Until end of protocol treatment after 24 weeks
Changes in bone marrow fibrosis
Time frame: Until end of protocol treatment after 24 weeks
Safety
Time frame: until 30 days following the last dose of tasquinimod as protocol treatment
Overall survival
Time frame: Until 3 years after enrollment
Anemia response
Time frame: Until end of protocol treatment after 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- HOVON websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Myelofibrosis
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 3
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Myelofibrosis, Anemia
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter te Boekhorst, Dr. principal investigator
Erasmus Medical Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tasquinimod in people with Myelofibrosis, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter te Boekhorst, Dr. (0031107041560, hovon@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR35W24 (time frame: 24 weeks after start treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.