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New treatment option for Myelofibrosis
Official title Tasquinimod in Patients with Myelofibrosis Refractory to or Intolerant for JAK2 Inhibition
ClinicalTrials.gov ID: NCT06605586
What this study is testing
What is Tasquinimod?
Tasquinimod is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for myelofibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Spleen ≥5 cm below costal margin as measured by palpation.
- Age ≥18 years.
You likely can't join if
- 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
See the full eligibility criteria
Who can 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%.
- 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...
- Patient is capable of giving informed consent.
- Written informed consent.
What rules you out
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- Any chemotherapy, immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), anagrelide, immunosuppressive therapy, corticosteroids \>10 mg/day prednisone or equivalent, or growth factor treatment (eg...
- 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...
- Current participation (during treatment treatment) in another clinical trial.
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, Germany
- Amsterdam, Netherlands
- Groningen, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, Germany; Amsterdam, Netherlands; Groningen, Netherlands; Nijmegen, Netherlands; Rotterdam, Netherlands; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.