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New treatment option for Acute Myeloid Leukemia
Official title Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents
ClinicalTrials.gov ID: NCT05442216
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 acute myeloid leukemia.
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
- A treatment cycle is 28 days. Tagraxofusp will be administered at 9 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 3 consecutive days (or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), followed by azacitidine administered at 75 mg/m2 SQ or IV daily on Day 4 through Day 10.
- 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
- Subject must meet all of the following applicable to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be...
- people must have newly diagnosed, untreated AML, as defined by ≥ 20% blasts in peripheral blood or bone marrow by manual aspirate differential...
- people must have documented CD123 positivity on leukemia cells by a centralized flow cytometry assay (Hematologics).
- Documented diagnosis of prior MDS, CMML, MDS/MPN overlap syndromes, or MPN's according to WHO criteria. people must have received at least 2 cycles...
You likely can't join if
- people meeting any of the criteria below may not participate in the study:
- people who are suitable for and are willing to receive intensive chemotherapy.
- Diagnosis of acute promyelocytic leukemia.
- Known CNS involvement with AML.
- Previous receipt of tagraxofusp.
- Treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of registration. NOTE: hydroxyurea, leukapheresis and/or...
See the full eligibility criteria
- Subject must meet all of the following applicable to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- people must have newly diagnosed, untreated AML, as defined by ≥ 20% blasts in peripheral blood or bone marrow by manual aspirate differential, immunohistochemistry staining, or flow cytometry, as defined by standard...
- people must have documented CD123 positivity on leukemia cells by a centralized flow cytometry assay (Hematologics).
- Documented diagnosis of prior MDS, CMML, MDS/MPN overlap syndromes, or MPN's according to WHO criteria. people must have received at least 2 cycles of hypomethylating agents (azacitidine or decitabine or oral...
- WBC \< 30 x 109 /µL- people with WBC ≥ 30 x 109 /µL may still be eligible after receiving cytoreduction measures such as hydroxyurea, and/or leukapheresis, if WBC \< 30 x 109 /µL prior to study treatment initiation...
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-2.
- Demonstrate adequate organ function within 28 days prior to registration.
- Left ventricular ejection fraction (LVEF) ≥ 45%.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone...
- Females of childbearing potential and male participants must be willing to use effective contraception as outlined in the protocol.
- Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
- Patients with known evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must...
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
- people meeting any of the criteria below may not participate in the study:
- people who are suitable for and are willing to receive intensive chemotherapy.
- Diagnosis of acute promyelocytic leukemia.
- Known CNS involvement with AML.
- Previous receipt of tagraxofusp.
- Treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of registration. NOTE: hydroxyurea, leukapheresis and/or cyclophosphamide are allowed prior to study entry per the protocol.
- Treatment with investigational drug within 21 days of registration.
- Previous allogeneic stem cell transplant within 60 days prior to registration.
- Receiving immunosuppression therapy, with the exception of prednisone ≤ 10mg/d, for the treatment or prophylaxis of GVHD. If the patient has been on immunosuppressant treatment or prophylaxis for GVHD, the treatment...
- History of other malignancies (excluding MDS, CMML, MDS/MPN, MPN's) within 2 years prior to reigstration, with the exception of: adequately treated in situ carcinoma of the cervix, breast, prostate; basal cell carcinoma...
- Clinically significant cardiac disease or abnormalities, defined as any of the following:
- QTcF ≥ 480 ms (using Fridericia's correction; mean of triplicate ECGs at screening).
- Myocardial infarction, unstable angina, or poorly controlled atrial fibrillation within 12 months prior to registration.
- Inadequate rate control, defined as either: Resting heart rate \> 80 bpm on ≥ 2 twelve-lead ECGs obtained ≥ 24 hours apart; OR Hemodynamic/Clinical Instability: Evidence of tachycardia-mediated cardiomyopathy...
- Symptom Burden (modified European Heart Rhythm Association [mEHRA]): mEHRA Class 3 (severe symptoms, normal daily activity affected) or Class 4 (disabling symptoms, normal daily activity discontinued), or any...
- Treatment-Refractory Status: Persistence of the above criteria despite ≥2 rate-control agents at guideline-recommended doses (e.g., beta-blocker, non-dihydropyridine calcium-channel blocker, or digoxin), or documented...
- Stroke within 6 months of registration
- Any history of:
- Congenital long QT syndrome
- Sustained ventricular tachycardia requiring intervention
- Ventricular fibrillation
- Torsades de pointes
- Presence at screening of:
- Second- or third-degree AV block without a permanent pacemaker
- Bi-fascicular block (right bundle branch block [RBBB] with left anterior hemiblock)
- Complete left bundle branch block
- Uncontrolled CHF
- Cardiac insufficiency Grade III or IV per New York Heart Association (NYHA) classification
- Uncontrolled hypertension
- Clinically significant abnormalities on a 12-lead electrocardiogram
- Uncontrolled significant pulmonary disease (e.g., COPD, pulmonary hypertension) that in the opinion of the investigator would put the patient at significant risk for pulmonary complications during the study.
- Active uncontrolled or severe systemic infection. Enrollment is possible after control of infection, at discretion of the treating physician.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Other severe medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Orlando, Florida, United States
- Buffalo, New York, United States
- Chapel Hill, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Miami, Florida, United States; Orlando, Florida, United States; Buffalo, New York, United States; Chapel Hill, North Carolina, United States; Winston-Salem, North Carolina, United States; Philadelphia, Pennsylvania, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.