Acute Myeloid LeukemiaPhase 1GO-TAGNCT05716009
Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML
A Phase 1 study testing Dose Escalation -tagraxofusp-erzs and Dose Expansion at RP2D -tagraxofusp-erzs in people with Acute Myeloid Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This is an open-label Phase Ia/Ib clinical study of tagraxofusp-erzs, a novel cytokine-drug conjugate that links interleukin-3 with a truncated diphtheria toxin, in combination with gemtuzumab ozogamicin for patients with relapsed/refractory AML. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Dose Escalation -tagraxofusp-erzs and Dose Expansion at RP2D -tagraxofusp-erzs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 16 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Histologically confirmed diagnosis of acute myeloid leukemia (AML) according per 2016 World Health Organization (WHO) criteria.
- Cluster of differentiation marker (CD)33 and CD123 / interleukin (IL)3RA expression on the subject's blasts, determined by standard Flow AML MRD assay.
- Age ≥ 12
- Relapsed or refractory after one cycle of prior therapy (cytoreductive agents such as hydroxyurea, cyclophosphamide, or a single dose of gemtuzumab ozogamicin are not considered prior treatment regimens).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- Adequate baseline organ function, including cardiac, renal, and hepatic function as defined by:
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- Left ventricular ejection fraction (LVEF) ≥ 50% by multi-gated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram (ECHO) within 28 days prior to the start of therapy
- No clinically significant abnormalities on a 12-lead electrocardiogram (ECG)
- Creatinine Clearance (CrCl) ≥ 60mL/min
- Serum albumin ≥ 3.2 g/dL (note that albumin infusions are not permitted in order to enable eligibility)
- Total bilirubin ≤ 1.5 mg/dL
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN)
- white blood cell (WBC) < 20,000/uL on day of first therapy, cytoreduction may be achieved using hydroxyurea.
- Ability to understand and willingness to sign a written informed consent document.
- Able to adhere to study visit schedule and other protocol requirements including follow up for survival assessment.
- If the patient is a woman of child-bearing potential (WOCBP), they should have a negative serum or urine pregnancy test within 1 week prior to tagraxofusp-erzs treatment. (Note: WOCBP include any female who has experienced menarche and who has not undergone successful sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level ≥ 35 milli-international units per milliliter (mIU/mL).
- Patients agree to use acceptable contraceptive methods for the duration of time in the study, and to continue to use acceptable contraceptive methods for 1 week after the last tagraxofusp-erzs infusion.
- The patient 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.
Who cannot join
- • Prior treatment with tagraxofusp-erzs.
- Primary resistance to or progression on gemtuzumab. Patients who have previously received Gemtuzumab, but whose disease was not resistant or did not progress on it are eligible.
- Active central nervous system involvement. Patients with a history of central nervous system involvement that has cleared with prior treatments are eligible.
- Blood or bone marrow transplant within 60 days of screening or active graft versus host disease.
- 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 supportive measures (excluding alopecia, nausea, and fatigue)
- The patient has received treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of study entry.
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- 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 and/or ongoing active malignancy must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, organ-confined prostate cancer with no evidence of progressive disease.
- The patient has clinically significant cardiovascular disease (e.g. uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
- 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 risk for pulmonary complications during the study.
- The patient is receiving immunosuppressive therapy - with the exception of low-dose prednisone (≤10 mg/day) - for treatment or prophylaxis of graft-versus-host disease (GVHD). If the patient has been on immunosuppressive treatment or prophylaxis for GVHD, the treatment(s) must have been discontinued at least 14 days prior to study treatment and there must be no evidence of Grade ≥ 2 GVHD.
- The patient has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements.
- The patient is pregnant or breastfeeding.
- The patient has a history of human immunodeficiency virus (HIV) infection, active or chronic Hepatitis B, or Hepatitis C.
- The patient has any condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: A Phase Ia/Ib Study of Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML
This is an open-label Phase Ia/Ib clinical study of tagraxofusp-erzs, a novel cytokine-drug conjugate that links interleukin-3 with a truncated diphtheria toxin, in combination with gemtuzumab ozogamicin for patients with relapsed/refractory AML.
The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of tagraxofusp-erzs in combination with gemtuzumab ozogamicin in this patient population. Then, once RP2D is determined, to determine the safety and tolerability of combination gemtuzumab and tagraxofusp-erzs when administered at the RP2D.
Read the detailed description
The goal of this study is to study the safety and tolerability of a novel combination of medications in relapsed or refractory AML: tagraxofusp and gemtuzumab ozogamicin. If the combination is found to be safe, then further studies will be done to determine whether this combination is effective for AML.
The first part of this study is called phase 1A. This part of the study is done to determine the optimal dose of tagraxofusp that can be given with gemtuzumab. The main purpose of phase 1A is to test different doses of the study drug, starting with the lowest dose and determining the optimal dose.
In phase 1B (the second part of the study), this dose will be given along with gemtuzumab to a larger group of patients to further test the safety and tolerability of this combination. The results of phase IB will also be used to determine whether the combination of tagraxofusp, when given at the optimal dose, and gemtuzumab are effective in treating AML. Substances (biomarkers) found in the blood and bone marrow will be drawn from patients in the course of this study to better understand whether the combination is effective against AML.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Dose Escalation -tagraxofusp-erzs, Dose Expansion at RP2D -tagraxofusp-erzs
- Keywords
- AML, tagraxofusp, Stemline, CD123, Go-TAG
- 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.
Dose Escalation -tagraxofusp-erzsDrug
Also called gemtuzumab ozogamicin
Sequential dose levels of tagraxofusp-erzs dependent on patient response. Fixed doses of gemtuzumab ozogamicin 3mg/m2/day on days 1, 4, and 7 of cycle 1 then on Day 1 or all subsequent cycles for a total of 3 cycles.
Dose Expansion at RP2D -tagraxofusp-erzsDrug
Also called gemtuzumab ozogamicin
Following the dose escalation portion, the expansion dose and schedule (RP2D) will be determined. Patients will continue to receive fixed doses of gemtuzumab ozogamicin 3mg/m2/day on days 1, 4, and 7 of cycle 1 then on Day 1 or all subsequent cycles for a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation of tagraxofusp-erzs in r/r AML | Experimental | Tagraxofusp-erzs and gemtuzumab ozogamicin (GO) will be administered every 4 weeks with 28 days defined as a treatment cycle. Tagraxofusp-erzs dose escalation for cycles 1-4 in combination with fixed dose GO.
This is a dose escalation design . The dose-limiting toxicity (DLT) period will be the 28 days following the first dose of GO. The initial dose level 1 (DL1) cohort will receive GO 3mg/m2 (capped at a maximum dose of 4.5mg) intravenously (IV) on cycle 1 days 1, 4, and 7 and tagraxofusp-erzs at an initial dose of 7μg/kg/day on days 10, 11, 12. For subsequent cycles of DL1, GO will continue to be administered at a dose of 3mg/m2 IV on day 1 and tagraxofusp-erzs will be administered IV at a dose of 7μg/kg/day on days 4,5,and 6. Subsequent escalation dose levels will receive tagraxofusp-erzs doses of 7mcg/kg/day, 9mcg/kg/day or 12mcg/kg/day. Initial cycle doses of tagraxofusp at these levels will be given on Days 5,6 and 7, then in subsequent cycles on days 1,2 and 3. Receives: Drug: Dose Escalation -tagraxofusp-erzs |
| Phase 1b recommended Phase 2 dose (RP2D) of tagraxofusp- erzs in r/r AML | Experimental | This is dose expansion at the RP2D of tagraxofusp. Participants with relapsed or refractory acute myeloid leukemia (r/r AML) will receive the RP2D of tagraxofusp-erzs, as determined in Phase 1a, and gemtuzumab at a dose of 3mg/m2 (max absolute dose of 4.5mg) on days 1,4, and 7 of cycle 1 and day 1 of subsequent cycles. Receives: Drug: Dose Expansion at RP2D -tagraxofusp-erzs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the recommended phase 2 dose (RP2D) of tagraxofusp-erzs in combination with gemtuzumab ozogamicin in patient with relapsed or refractory acute myeloid leukemia (AML)
Identification of a RP2D with a target toxicity rate of 0.2 or less based on number of adverse events defined by CTCAE v5.0 criteria
Measured: 2.5 years
Determination of the safety and tolerability of combination gemtuzumab and tagraxofusp-erzs when administered at the RP2D.
Assessment of RP2D safety and tolerability based on number of adverse events defined by CTCAE v5.0 criteria
Measured: 2.5 years
Secondary outcomes (5)
Progression free survival
Number of patients who survive from date of 1st dose to date of disease progression or death from any cause. Will be censored at last response assessment date.
Measured: 2.5 years
Overall Survival
Estimated using the method of Kaplan and Meier, number of deaths calculated from date of first dose to date of death or last known follow up.
Measured: 2.5 years
Overall response rate
Estimate overall response rate at the RP2D, defined as a composite of complete remission(CR), CR with partial recovery, CR with incomplete hematologic recovery, morphologic leukemia free state, and partial remission, according to the 2022 international consensus classification (ICC) of myeloid neoplasms
Measured: 2.5 years
Time to response
Assess the amount of time to respond to treatment from date of first dose to date of first response according to ICC response definitions determined by physician.
Measured: 2.5 years
Duration of response
Assess the amount of time elapsed from first response according to ICC response definitions determined by physician. to first disease progression, last follow up date or death.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start20 Nov 2023
- Primary completion5 May 2025
- Study completion16 Jul 2025
Why it stopped: Upon analysis of the first 7 participants accrued, it was determined that this combination treatment is not efficacious as treatment for patients with relapsed or refractory AML
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.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Tagraxofusp-erzs dose escalation study combined with a fixed dose of gemtuzumab ozogamicin 3mg/m2/day on days 1, 4, and 7. Dose level 1, cycle 1 of tagraxofusp-erzs will be 7mcg/kg/day on days 10, 11 and 12. Subsequent cycles at dose level 1 will consist of gemtuzumab ozogamicin 3mg/m2/day on day 1 and tagraxofusp-erzs 7mcg/kg/day on days 4, 5, and 6. For dose levels 2 through 4, gemtuzumab will continue to be administered at a fixed dose of 3mg/m2/day on days 1, 4, and 7 while tagraxofusp-erzs will be administered at escalating doses of 9mcg/kg/day then 12mcg/kg/day on days 5, 6, and 7 of cycle 1 and days 1, 2, and 3 of subsequent cycles.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- StemlineTherapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Alexander Ambinder, MD, Principal investigator, SKCCC Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716009
- Sponsor's protocol ID
- J2287
- Other IDs
- IRB00350653
- Acronym
- GO-TAG
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2023
- Last updated
- 25 Jun 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Study of Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML
- ClinicalTrials.gov ID
- NCT05716009
- Acronym / sponsor ID
- GO-TAG / J2287
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, tagraxofusp, Stemline, CD123, Go-TAG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Upon analysis of the first 7 participants accrued, it was determined that this combination treatment is not efficacious as treatment for patients with relapsed or refractory AML
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- StemlineTherapeutics, Inc.
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 8 Feb 2023 (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.
This is an open-label Phase Ia/Ib clinical study of tagraxofusp-erzs, a novel cytokine-drug conjugate that links interleukin-3 with a truncated diphtheria toxin, in combination with gemtuzumab ozogamicin for patients with relapsed/refractory AML.
The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of tagraxofusp-erzs in combination with gemtuzumab ozogamicin in this patient population. Then, once RP2D is determined, to determine the safety and tolerability of combination gemtuzumab and tagraxofusp-erzs when administered at the RP2D.
Detailed description
The goal of this study is to study the safety and tolerability of a novel combination of medications in relapsed or refractory AML: tagraxofusp and gemtuzumab ozogamicin. If the combination is found to be safe, then further studies will be done to determine whether this combination is effective for AML.
The first part of this study is called phase 1A. This part of the study is done to determine the optimal dose of tagraxofusp that can be given with gemtuzumab. The main purpose of phase 1A is to test different doses of the study drug, starting with the lowest dose and determining the optimal dose.
In phase 1B (the second part of the study), this dose will be given along with gemtuzumab to a larger group of patients to further test the safety and tolerability of this combination. The results of phase IB will also be used to determine whether the combination of tagraxofusp, when given at the optimal dose, and gemtuzumab are effective in treating AML. Substances (biomarkers) found in the blood and bone marrow will be drawn from patients in the course of this study to better understand whether the combination is effective against AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Tagraxofusp-erzs dose escalation study combined with a fixed dose of gemtuzumab ozogamicin 3mg/m2/day on days 1, 4, and 7. Dose level 1, cycle 1 of tagraxofusp-erzs will be 7mcg/kg/day on days 10, 11 and 12. Subsequent cycles at dose level 1 will consist of gemtuzumab ozogamicin 3mg/m2/day on day 1 and tagraxofusp-erzs 7mcg/kg/day on days 4, 5, and 6. For dose levels 2 through 4, gemtuzumab will continue to be administered at a fixed dose of 3mg/m2/day on days 1, 4, and 7 while tagraxofusp-erzs will be administered at escalating doses of 9mcg/kg/day then 12mcg/kg/day on days 5, 6, and 7 of cycle 1 and days 1, 2, and 3 of subsequent cycles.
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation of tagraxofusp-erzs in r/r AML | Experimental | Drug: Dose Escalation -tagraxofusp-erzsTagraxofusp-erzs and gemtuzumab ozogamicin (GO) will be administered every 4 weeks with 28 days defined as a treatment cycle. Tagraxofusp-erzs dose escalation for cycles 1-4 in combination with fixed dose GO. This is a dose escalation design . The dose-limiting toxicity (DLT) period will be the 28 days following the first dose of GO. The initial dose level 1 (DL1) cohort will receive GO 3mg/m2 (capped at a maximum dose of 4.5mg) intravenously (IV) on cycle 1 days 1, 4, and 7 and tagraxofusp-erzs at an initial dose of 7μg/kg/day on days 10, 11, 12. For subsequent cycles of DL1, GO will continue to be administered at a dose of 3mg/m2 IV on day 1 and tagraxofusp-erzs will be administered IV at a dose of 7μg/kg/day on days 4,5,and 6. Subsequent escalation dose levels will receive tagraxofusp-erzs doses of 7mcg/kg/day, 9mcg/kg/day or 12mcg/kg/day. Initial cycle doses of tagraxofusp at these levels will be given on Days 5,6 and 7, then in subsequent cycles on days 1,2 and 3. |
| Phase 1b recommended Phase 2 dose (RP2D) of tagraxofusp- erzs in r/r AML | Experimental | Drug: Dose Expansion at RP2D -tagraxofusp-erzsThis is dose expansion at the RP2D of tagraxofusp. Participants with relapsed or refractory acute myeloid leukemia (r/r AML) will receive the RP2D of tagraxofusp-erzs, as determined in Phase 1a, and gemtuzumab at a dose of 3mg/m2 (max absolute dose of 4.5mg) on days 1,4, and 7 of cycle 1 and day 1 of subsequent cycles. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- • Histologically confirmed diagnosis of acute myeloid leukemia (AML) according per 2016 World Health Organization (WHO) criteria.
Key exclusion criteria (14 listed)
- • Prior treatment with tagraxofusp-erzs.
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 |
|---|---|---|
| Dose Escalation -tagraxofusp-erzsAlso: gemtuzumab ozogamicinSequential dose levels of tagraxofusp-erzs dependent on patient response. Fixed doses of gemtuzumab ozogamicin 3mg/m2/day on days 1, 4, and 7 of cycle 1 then on Day 1 or all subsequent cycles for a total of 3 cycles. | Drug | Phase 1a Dose Escalation of tagraxofusp-erzs in r/r AML |
| Dose Expansion at RP2D -tagraxofusp-erzsAlso: gemtuzumab ozogamicinFollowing the dose escalation portion, the expansion dose and schedule (RP2D) will be determined. Patients will continue to receive fixed doses of gemtuzumab ozogamicin 3mg/m2/day on days 1, 4, and 7 of cycle 1 then on Day 1 or all subsequent cycles for a total of 3 cycles. | Drug | Phase 1b recommended Phase 2 dose (RP2D) of tagraxofusp- erzs in r/r AML |
Primary outcome
Determination of the recommended phase 2 dose (RP2D) of tagraxofusp-erzs in combination with gemtuzumab ozogamicin in patient with relapsed or refractory acute myeloid leukemia (AML)
Time frame: 2.5 years
Identification of a RP2D with a target toxicity rate of 0.2 or less based on number of adverse events defined by CTCAE v5.0 criteria
Determination of the safety and tolerability of combination gemtuzumab and tagraxofusp-erzs when administered at the RP2D.
Time frame: 2.5 years
Assessment of RP2D safety and tolerability based on number of adverse events defined by CTCAE v5.0 criteria
5 secondary outcomes
Progression free survival
Time frame: 2.5 years
Overall Survival
Time frame: 2.5 years
Overall response rate
Time frame: 2.5 years
Time to response
Time frame: 2.5 years
Duration of response
Time frame: 2.5 years
Results and safety
The study was stopped early (reason given: Upon analysis of the first 7 participants accrued, it was determined that this combination treatment is not efficacious as treatment for patients with relapsed or refractory AML). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 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. This study is not recruiting at the moment.
Alexander Ambinder, MD principal investigator
SKCCC Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose Escalation -tagraxofusp-erzs and Dose Expansion at RP2D -tagraxofusp-erzs in people with Acute Myeloid Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 18 inclusion and 14 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: stopped early, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Upon analysis of the first 7 participants accrued, it was determined that this combination treatment is not efficacious as treatment for patients with relapsed or refractory AML). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the recommended phase 2 dose (RP2D) of tagraxofusp-erzs in combination with gemtuzumab ozogamicin in patient with relapsed or refractory acute myeloid leukemia (AML) (time frame: 2.5 years). 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 25 Jun 2026.