Acute Myeloid LeukemiaPhase 2TAGALONGNCT05442216
Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents
A Phase 2 study testing Tagraxofusp, Azacitidine and Venetoclax in people with Acute Myeloid Leukemia, run by Joshua Zeidner at 7 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Tagraxofusp, Azacitidine and Venetoclax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 May 2024to 21 Jul 2031
- Phase
- Phase 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
- Subject must meet all of the following applicable inclusion criteria 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.
- Subjects 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 WHO 2016 diagnostic criteria.
- Subjects 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. Subjects must have received at least 2 cycles of hypomethylating agents (azacitidine or decitabine or oral decitabine/cedazuridine) for the management of MDS, CMML, MDS/MPN overlap syndromes, or MPN's. NOTE: Subjects who have enrolled on clinical trials with investigational agents in combination with HMA's will still be eligible. Investigational agents must have been discontinued >14 days prior to study treatment initiation. Subjects who have enrolled on clinical trials with investigational agents in combination with HMA's will still be eligible. Investigational agents must have been discontinued > 21 days prior to study treatment initiation.
- WBC < 30 x 109 /µL- subjects 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. Cytoreduction with hydroxyurea, leukapheresis and/or cyclophosphamide is allowed prior to treatment. Hydroxyurea must be discontinued ≥ 12 hours prior to study treatment initiation. Cyclophosphamide must be discontinued ≥ 5 days prior to study treatment initiation.
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- 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 a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
- 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 have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial.
- 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.
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Subjects 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.
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- 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 must have been discontinued at least 14 days prior to study treatment initiation and there must be no evidence of Grade ≥ 2 GVHD.
- 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 of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. Subjects receiving maintenance or adjuvant therapy for organ-confined malignancy such as breast or prostate cancer are eligible. Maintenance and/or adjuvant chemotherapy must be discontinued >72 hours prior to study treatment initiation. Those with substantial potential for recurrence and/or ongoing active malignancy must be discussed with the sponsor-investigator before registration.
- 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, decompensated heart failure attributed to atrial fibrillation, or hemodynamic instability (symptomatic hypotension, end-organ hypoperfusion) requiring urgent rate or rhythm intervention.
- 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 cardiac-related syncope.
- 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 intolerance preventing adequate dosing.
- 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 of study results, and in the judgement of the investigator would make the patient inappropriate for enrollment in this study. This may include psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Katherine Collins, Katherine.Collins@RoswellPark.org
Steven Green, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Allison McKinney, allison_mckinney@med.unc.edu
Joshua Zeidner, MD
- Recruiting
University of Miami
Miami, Florida, 33136
Alessia Zoso, 305-243-8246, azoso@miami.edu
Namrata Chandhok, MD
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Kristen Wing, Clinical Research Supervisor, 407-303-8251, Kristen.Wing@adventhealth.com
Brian Parkin, MD
- Recruiting
Penn Medicine Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Thomas Greenwood, thomas.greenwood@pennmedicine.upenn.edu
Catherine Lai, MD
- Recruiting
Lifespan Health System Rhode Island Hospital
Providence, Rhode Island, 46278
Caylee Carmody, ccarmody@lifespan.org
John Reagan, MD
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Lauren Vaile, 336-713-5440, lauren.vaile@advocatehealth.org
Lindsay Holder, lindsay.holder@advocatehealth.org
About this study
Official title: Phase II Study of TAGraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Previous Exposure to HypOmethylatiNG Agents
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. Venetoclax will begin on Day 4 and continue through Day 24 (21 consecutive days). A bone marrow biopsy (BM Bx) will be performed on Day 24 (+3 days) of Cycle 1.
Subjects who do not achieve a CRm will proceed with the next cycle of Induction Phase study treatment, irrespective of hematologic laboratory values. Cycle 2+ will consist of tagraxofusp 9 mcg/kg IV over 15 minutes daily for 3 consecutive days (Day 1-3 or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), azacitidine 75 mg/m2 SQ or IV on Day 1 through Day 7 or Days 1-7 or 1-5, 8-9 and venetoclax 400 mg daily Day 1 through Day 21.
Read more
A bone marrow biopsy (BM Bx) will be performed on Day 21 (+3 days) of Cycle 2. If a CRm is obtained or maintained, the subject will move to or remain on the Continuation Phase. Subjects who do not achieve a marrow CR (CRm) after Cycle 2 will proceed with the next cycle of Induction Phase study treatment as described above, irrespective of hematologic laboratory values. If a CRm is obtained after Cycle 3 or 4, the subject will move to the Continuation Phase .
If a CRm is not obtained after Cycle 4, study treatment will be discontinued and the subject will move to follow up. If per the investigator, the subject is receiving clinical benefit, study treatment may continue until toxicity or completion of 12 total cycles. A BM Bx will be performed at least every 3 cycles for these subjects.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Tagraxofusp, Azacitidine, Venetoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TagraxofuspDrug
9 mcg/kg intravenously Days 1-3
AzacitidineDrug
75 mg/m2 subcutaneously or intravenously Days 1-7
VenetoclaxDrug
400 mg daily Days 1-21.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Each treatment cycle will last 28 days. For Cycle 1, tagraxofusp 9 mcg/kg IV over 15 minutes daily for 3 consecutive days followed by azacitidine administered at 75 mg/m2 SQ or IV daily on Day 4 through Day 10. Venetoclax with ramp-up dosing on Day 4 through Day 24. A bone marrow biopsy (BM Bx) will be performed on Day 24 (+3 days) of Cycle 1. If a CRm is obtained, the subject will move to the Continuation Phase. Subjects who do not achieve a CRm will proceed with the next cycle of Induction Phase study treatment.
Cycle 2+ will consist of tagraxofusp 9 mcg/kg IV over 15 minutes daily (Day 1-3), azacitidine 75 mg/m2 SQ or IV on Day 1 through Day 7 or Days 1-7 or 1-5, 8-9 and venetoclax 400 mg daily Day 1 through Day 21. BM Bx will be performed on Day 21 (+3 days) of Cycle 2. If a CRm is obtained or maintained, the subject will move to or remain on the Continuation Phase. If a CRm is not obtained after Cycle 4, study treatment will be discontinued and the subject will move to follow up Receives: Drug: Tagraxofusp; Drug: Azacitidine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
The CR rate based on ELN AML response criteria in subjects with newly diagnosed AML with p-HMA receiving tagraxofusp and azacitidine and venetoclax
Measured: 5 years
Secondary outcomes (9)
Assess adverse events
Describe overall toxicity of tagraxofusp and azacitidine and venetoclax. The frequency and nature of adverse events will be assessed by NCI CTCAE v5.0.
Measured: 4 months
Rate of CR + CRh
Estimate the rate of CR + CRh in subjects with newly diagnosed AML with p-HMA receiving tagraxofusp and azacitidine and venetoclax.The rate of CR + CRh is defined as bone marrow myeloblasts of < 5% combined with both absolute neutrophil count > 500/μL and platelet count > 50 × 109/L.
Measured: 5 years
Rate of CR without evidence of Minimal Residual Disease (MRD)
CR without evidence of MRD in subjects with newly diagnosed AML with p-HMA receiving tagraxofusp and azacitidine and venetoclax based on ELN AML response criteria.
Measured: 5 years
Overall Response Rate (ORR)
Estimate the ORR in patients with newly diagnosed AML with p-HMA who receive tagraxofusp and azacitidine and venetoclax. ORR (partial remission [PR] + CR + CRi + morphological leukemia-free state [MLFS]) as defined by ELN-2017.
Measured: 5 years
Overall Survival (OS)
Estimate OS in subjects with newly diagnosed AML with p-HMA receiving tagraxofusp and azacitidine and venetoclax. OS is defined as time from initiation of treatment until death or last follow-up.
Measured: 5 years
Disease Free Survival (DFS)
Estimate the DFS in subjects with newly diagnosed AML with p-HMA after receiving tagraxofusp and azacitidine and venetoclax. DFS is defined as time from CR/CRi until relapse, death, or last follow-up, as based on ELN-2017.
Measured: 5 years
Recurrence Free Survival (RFS)
Estimate the recurrence free survival (RFS) in subjects with newly diagnosed AML with p-HMA after receiving tagraxofusp and azacitidine and venetoclax. RFS is defined as time from ORR until progression, relapse, or death. Subjects who have not progressed will be right-censored at the date of the last disease evaluation.
Measured: 5 years
Event-Free Survival (EFS)
Estimate the event-free survival (EFS) in subjects with newly diagnosed AML with p-HMA receiving tagraxofusp and azacitidine and venetoclax. EFS is defined as time from initiation of treatment until no response (after 2 cycles of tagraxofusp), relapse or death.
Measured: 5 years
Rate of allogeneic stem cell transplant
Estimate the rate of allogeneic stem cell transplant in subjects with newly diagnosed AML with p-HMA receiving tagraxofusp and azacitidine and venetoclax.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 May 2024
- Primary completion21 Jul 2030 (estimated)
- Study completion21 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua Zeidner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Zeidner, Hoosier Cancer Research Network
- Investigators
- Joshua Zeidner, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442216
- Sponsor's protocol ID
- HCRN AML20-472
- Acronym
- TAGALONG
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of TAGraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Previous Exposure to HypOmethylatiNG Agents
- ClinicalTrials.gov ID
- NCT05442216
- Acronym / sponsor ID
- TAGALONG / HCRN AML20-472
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Joshua ZeidnerUniversity, hospital or other
- Collaborators
- Stemline Therapeutics, Inc., University of North Carolina, Chapel Hill
- Study start
- 1 May 2024 (actual)
- Primary completion
- 21 Jul 2030 (estimated)
- Study completion
- 21 Jul 2031 (estimated)
- First posted
- 1 Jul 2022 (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.
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. Venetoclax will begin on Day 4 and continue through Day 24 (21 consecutive days). A bone marrow biopsy (BM Bx) will be performed on Day 24 (+3 days) of Cycle 1.
Subjects who do not achieve a CRm will proceed with the next cycle of Induction Phase study treatment, irrespective of hematologic laboratory values. Cycle 2+ will consist of tagraxofusp 9 mcg/kg IV over 15 minutes daily for 3 consecutive days (Day 1-3 or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), azacitidine 75 mg/m2 SQ or IV on Day 1 through Day 7 or Days 1-7 or 1-5, 8-9 and venetoclax 400 mg daily Day 1 through Day 21.
A bone marrow biopsy (BM Bx) will be performed on Day 21 (+3 days) of Cycle 2. If a CRm is obtained or maintained, the subject will move to or remain on the Continuation Phase. Subjects who do not achieve a marrow CR (CRm) after Cycle 2 will proceed with the next cycle of Induction Phase study treatment as described above, irrespective of hematologic laboratory values. If a CRm is obtained after Cycle 3 or 4, the subject will move to the Continuation Phase .
If a CRm is not obtained after Cycle 4, study treatment will be discontinued and the subject will move to follow up. If per the investigator, the subject is receiving clinical benefit, study treatment may continue until toxicity or completion of 12 total cycles. A BM Bx will be performed at least every 3 cycles for these subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Tagraxofusp, Drug: Azacitidine, Drug: VenetoclaxEach treatment cycle will last 28 days. For Cycle 1, tagraxofusp 9 mcg/kg IV over 15 minutes daily for 3 consecutive days followed by azacitidine administered at 75 mg/m2 SQ or IV daily on Day 4 through Day 10. Venetoclax with ramp-up dosing on Day 4 through Day 24. A bone marrow biopsy (BM Bx) will be performed on Day 24 (+3 days) of Cycle 1. If a CRm is obtained, the subject will move to the Continuation Phase. Subjects who do not achieve a CRm will proceed with the next cycle of Induction Phase study treatment. Cycle 2+ will consist of tagraxofusp 9 mcg/kg IV over 15 minutes daily (Day 1-3), azacitidine 75 mg/m2 SQ or IV on Day 1 through Day 7 or Days 1-7 or 1-5, 8-9 and venetoclax 400 mg daily Day 1 through Day 21. BM Bx will be performed on Day 21 (+3 days) of Cycle 2. If a CRm is obtained or maintained, the subject will move to or remain on the Continuation Phase. If a CRm is not obtained after Cycle 4, study treatment will be discontinued and the subject will move to follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject must meet all of the following applicable inclusion criteria 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.
- Subjects 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 WHO 2016 diagnostic criteria.
- Subjects 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. Subjects must have received at least 2 cycles of hypomethylating agents (azacitidine or decitabine or oral decitabine/cedazuridine) for the management of MDS, CMML, MDS/MPN overlap syndromes, or MPN's. NOTE: Subjects who have enrolled on clinical trials with investigational agents in combination with HMA's will still be eligible. Investigational agents must have been discontinued >14 days prior to study treatment initiation. Subjects who have enrolled on clinical trials with investigational agents in combination with HMA's will still be eligible. Investigational agents must have been discontinued > 21 days prior to study treatment initiation.
Key exclusion criteria (34 listed)
- Subjects 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.
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 |
|---|---|---|
| Tagraxofusp9 mcg/kg intravenously Days 1-3 | Drug | Experimental Group |
| Azacitidine75 mg/m2 subcutaneously or intravenously Days 1-7 | Drug | Experimental Group |
| Venetoclax400 mg daily Days 1-21. | Drug | Experimental Group |
Primary outcome
Complete Response
Time frame: 5 years
The CR rate based on ELN AML response criteria in subjects with newly diagnosed AML with p-HMA receiving tagraxofusp and azacitidine and venetoclax
9 secondary outcomes
Assess adverse events
Time frame: 4 months
Rate of CR + CRh
Time frame: 5 years
Rate of CR without evidence of Minimal Residual Disease (MRD)
Time frame: 5 years
Overall Response Rate (ORR)
Time frame: 5 years
Overall Survival (OS)
Time frame: 5 years
Disease Free Survival (DFS)
Time frame: 5 years
Recurrence Free Survival (RFS)
Time frame: 5 years
Event-Free Survival (EFS)
Time frame: 5 years
Rate of allogeneic stem cell transplant
Time frame: 4 months
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 10 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Joshua Zeidner, MD principal investigator
University of North Carolina, Chapel Hill
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tagraxofusp, Azacitidine and Venetoclax in people with Acute Myeloid Leukemia, run by Joshua Zeidner at 7 sites in United States.
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 15 inclusion and 34 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 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 phase mean?
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 Joshua Zeidner, MD (732-236-3903, joshua_zeidner@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (time frame: 5 years). 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 10 Jul 2026.