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New treatment option for Myelofibrosis，MF
Official title Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined
ClinicalTrials.gov ID: NCT06414681
What this study is testing
What is Tagraxofusp?
Tagraxofusp is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for myelofibrosis，mf.
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 open-label, single-center, pilot trial is to test the combination of Tagraxofusp (TAG) with Pacritinib (PAC) in patients with intermediate-II or higher myelofibrosis (MF), who have had prior therapy with the approved JAK1/2 inhibitor or in which therapy with the approved JAK1/2 inhibitors is not appropriate, contraindicated or declined by the subjects. The Primary Objective is to: 1\.
- Phase 1: an early, usually small safety study
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. Healthy volunteers may be eligible.
You may be able to join if
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written...
- The participant or LAR has signed informed consent prior to initiation of any study-specific procedures or treatment.
- The patient is able to adhere to the study visit schedule and other protocol requirements.
- Males and females age ≥ 18 years.
- ECOG Performance Status 0 - 2 (Appendix A).
You likely can't join if
- Simultaneously enrolled in any therapeutic clinical trial
- Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study.
- The patient has received treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of study entry.
- The patient has received treatment with another investigational agent within 14 days of study entry.
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation.
See the full eligibility criteria
Who can join
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
- The participant or LAR has signed informed consent prior to initiation of any study-specific procedures or treatment.
- The patient is able to adhere to the study visit schedule and other protocol requirements.
- Males and females age ≥ 18 years.
- ECOG Performance Status 0 - 2 (Appendix A).
- Life expectancy of \> 6 months.
- Patient meets the 2016 WHO diagnostic criteria for MF and has an IPSS/DIPSS/DIPSS-plus intermediate-II or higher-risk disease.
- Patients who have indications for therapy per investigator or patient's choice, such as Splenomegaly, \>5 CM BCM or mTSS ≥ 8 or mTSS Itching, night sweats, or bone pain ≥ 5 or Significant cytopenias including Hgb \<10...
- Patients treated with a JAK inhibitor for \>3 months and: had inadequate response to treatment, i.e., \< 10% reduction of spleen by imaging, or less than 25% reduction by spleen length on physical exam or lack of...
- A least 4 weeks have elapsed between the last dose of any MF-directed drug treatments, including hydroxyurea (HU), Interferon or glucocorticosteroids. NOTE: If patient is on a stable dose of glucocorticosteroids for...
- Patient is not eligible for an immediate allo-SCT.
- Adequate baseline organ, cardiac, and renal function as defined by: LVEF ≥ 50% by ECHO within 6 months of study treatment initiation No clinically significant abnormalities on a 12-lead ECG, and no QTcF ≥ 480 msec Serum...
- If the patient is a woman of child-bearing potential (WOCBP), they should have a negative serum pregnancy test no more than 7 days prior to start of treatment. (Note: WOCBP include any female who has experienced...
- Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the...
What rules you out
- Simultaneously enrolled in any therapeutic clinical trial
- Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study.
- The patient has received treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of study entry.
- The patient has received treatment with another investigational agent within 14 days of study entry.
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation.
- Any condition or other contraindication to therapy as deemed by the principal investigator to place the subject at an unacceptably high risk for toxicities.
- Is pregnant or breastfeeding.
- Has a known allergic reaction to any excipient contained in the study drug formulation.
- Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
- Prior therapy with Tagraxofusp or Pacritinib.
- Presence of peripheral blood or bone marrow blast count \> 10%
- Active Graft versus Host Disease (GVHD)
- For patients who have previously had Stem Cell Therapy (SCT) - The patient is receiving immunosuppressive therapy. EXCEPTION: low-dose prednisone (≤10 mg/day) - for treatment or prophylaxis of graft-versus-host disease...
- Other uncontrolled active malignancy as determined by the principal investigator
- The patient has an active malignancy and/or cancer history that may confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) with substantial potential for recurrence...
- The patient has clinically significant cardiovascular disease (e.g. uncontrolled or any New York Heart Association Class 2 or greater congestive heart failure, uncontrolled angina, history of myocardial infarction...
- Any gastrointestinal or metabolic condition that could interfere with absorption of oral medication.
- Prior therapy with Pacritinib (PAC) or Tagraxofusp (TAG).
- The patient has persistent clinically significant toxicities Grade ≥ 2 from previous therapies, including cytotoxic chemotherapy, targeted therapies, biological therapies, or immunotherapies, not readily controlled by...
- The patient has uncontrolled, clinically significant pulmonary disease (e.g. chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant...
- The patient has known active or suspected central nervous system (CNS) disease. If suspected, CNS disease should be ruled out with relevant imaging and/or examination of cerebrospinal fluid.
- Current systemic treatment with strong or moderate CYP3A4 inhibitor or P450 inducer. EXCEPTION: Patients who discontinue this treatment by Day 14 before start of treatment (Day -14) or 5 half-lives, whichever is shorter.
- Use of full-dose anticoagulation and use of anti-platelet therapy other than aspirin 81mg daily within 14 days prior to D1.
- Recent unprovoked bleeding of grade ≥ 2 within the last 3 months prior to Day 1.
- Active uncontrolled diarrhea or inflammatory bowel disease (IBD)
- Known sero-positivity for Hepatitis A (HAV), Hepatitis B (HBV), Hepatitis C (HCV), Human Immunodeficiency Virus (HIV)
- Patients with history of clinically significant bleeding or on anticoagulants
- Patients with moderate (Child-Pugh B ) and severe (Child -Pugh C) hepatic impairment will not be enrolled in the study.
- Patients with eGFR \< 30 mL/min will not be enrolled
The study team makes the final eligibility decision.
Where it's taking place
- Fairway, Kansas, United States
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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fairway, Kansas, United States. 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.