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Refractory Acute Myeloid LeukemiaPhase 1/2NCT06561152

Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML

A Phase 1/2 study testing Tagraxofusp, Cladribine (CLAD) and Cytarabine in people with Refractory Acute Myeloid Leukemia and Relapsed Acute Myeloid Leukemia, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To determine the efficacy of the combination of tagraxofusp, cladribine, and cytarabine. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tagraxofusp, Cladribine (CLAD) and Cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
10 Feb 2025to Oct 2028
Phase
Phase 1/2
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

  • Documented diagnosis of relapsed or refractory acute myeloid leukemia (AML) according to World Health Organization (WHO) 2022 criteria
  • Expression of CD123 by either flow cytometry or immunohistochemical staining with no minimum threshold for positivity
  • Must have received initial therapy with venetoclax in combination with a hypomethylating agent (either azacitidine or decitabine) with no subsequent therapy unless mutations in the IDH or FLT3 genes.
  • If mutations in the IDH or FLT3 genes, treatment with IDH or FLT3 inhibitors after initial failure of venetoclax plus HMA is allowed, but not required.
  • Age ≥ 18 years of age
  • ECOG ≤ 2
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  • Albumin ≥ 3.2 g/dL at time of screening (note that albumin supplementation is not permitted to enable eligibility)
  • Left ventricular ejection fraction ≥ 50%
  • No clinically significant abnormalities on 12-lead electrocardiogram (ECG) including: complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250ms, or QTcF (Friderica's method) >450ms in 3 successive measurements
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Females of reproductive potential need to either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with highly effective contraception without interruption prior to starting treatment, during the study therapy, and for 30 days after last dose of study therapy
  • For males of reproductive potential: agreement to use of condoms
  • Adequate hepatic/renal function defined as:
  • Hepatic function: total bilirubin ≤ 1.5 x ULN (unless attributable to Gilbert's disease or leukemic involvement) AND AST or ALT ≤ 3 x ULN
  • Renal function: creatinine clearance > 30 mL/minute, calculated by Cockcroft Gault formula
  • Women of childbearing potential must have a negative urine or serum pregnancy test
  • Ability to understand and the willingness to provide written informed consent.

Who cannot join

  • Prior therapy apart from Venetoclax in combination with a hypomethylating agent, or Venetoclax in combination with a hypomethylating agent followed by monotherapy with IDH or FLT3 inhibitors
  • Patients who received systemic anti-cancer therapy <14 days prior to their first day of study drug administration.
  • Patients who received systemic anti-cancer therapy <14 days prior to their first day of study drug administration. Concurrent hydroxyurea will be allowed. Hydroxyurea use will be allowed only during the first cycle if needed for disease control.
  • Significant cardiac disease (any NYHA Class 3 or 4 CHF, uncontrolled angina, history of MI, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication)
  • Any uncontrolled bacterial, fungal, viral or other infection.
  • Known HIV+ or active hepatitis B or C infection, defined as positive viral load for HBV or HCV or a positive surface antigen (HBsAg) test for hepatitis B.
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  • The patient has persistent clinically significant toxicities Grade >/= 2 from previous therapies not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue).
  • 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 study entry) with substantial potential for recurrence and/or ongoing active malignancy must be discussed with study team 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 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 has known active or suspected CNS disease. If suspected, CNS disease should be ruled out with relevant imaging and/or examination of cerebrospinal fluid.
  • The patient is receiving immunosuppressive therapy - with the exception of low-dose prednisone (</= 10 mg/day).
  • Received allogenic stem cell transplant prior to the treatment.
  • The patient has an 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.
  • Pregnant or breast feeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Woo In (Yustina) Cho contact

650-721-2443

wooin@stanford.edu

United States1 site, 1 recruiting

  • Stanford University

    Palo Alto, California, 94304

    Woo In (Yustina) Cho, 650-721-2443, wooin@stanford.edu

    Gabriel Mannis

    Recruiting

Other trials in United States

About this study

Official title: Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

To determine the efficacy of the combination of tagraxofusp, cladribine, and cytarabine.

Being tested
Tagraxofusp, Cladribine (CLAD), Cytarabine
Keywords
tagraxofusp, cladribine, cytarabine
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

    Tagraxofusp is administered by intravenous infusion (IV) over 15 minutes for 3 consecutive days of a 28-day cycle. (days 4-6)

  • Cladribine (CLAD)Drug

    Cladribine 5mg/m2 IV once daily on days 1-3 (DL1) Cladribine 5mg/m2 IV once daily on days 1-4 (DL2) Cladribine 5mg/m2 IV once daily on days 1-5 (DL3)

  • CytarabineDrug

    Cytarabine 20mg/m2 IV daily days 1-5 (DL1) Cytarabine 20mg/m2 IV daily days 1-7(DL2) cytarabine 20mg/m2 IV daily days 1-10 (DL3)

Study groups in NCT06561152
Study groupRoleWhat they receive
Dose level 1 (DL1)ExperimentalDL1 will consist of cladribine 5mg/m2 IV once daily on days 1-3, cytarabine 20mg/m2 IV daily days 1-5, and tagraxofusp 12 mcg/kg IV daily days 4-6. If a DLT is encountered in the first 2 participants, 3 more will be enrolled at the same dose.
Receives: Drug: Tagraxofusp; Drug: Cladribine (CLAD); Drug: Cytarabine
Dose level 2 (DL2)ExperimentalDL2 will consist of cladribine 5mg/m2 IV once daily on days 1-4, cytarabine 20mg/m2 IV daily days 1-7, and tagraxofusp 12 mcg/kg IV daily days 4-6. If a DLT is encountered in the first 2 participants, 3 more will be enrolled at the same dose.
Receives: Drug: Tagraxofusp; Drug: Cladribine (CLAD); Drug: Cytarabine
Dose level 3 (DL3)ExperimentalDL3 will consist of cladribine 5mg/m2 IV once daily on days 1-5, cytarabine 20mg/m2 IV daily days 1-10, and tagraxofusp 12 mcg/kg IV daily days 4-6. If a DLT is encountered in the first 2 participants, 3 more will be enrolled at the same dose.
Receives: Drug: Tagraxofusp; Drug: Cladribine (CLAD); Drug: Cytarabine
Dose Level -1 (DL-1)ExperimentalDL -1 will consist of cladribine 5mg/m2 IV once daily on days 1-2, cytarabine 20mg/m2 IV daily days 1-4, and tagraxofusp 12mcg/kg IV daily days 4-6.
Receives: Drug: Tagraxofusp; Drug: Cladribine (CLAD); Drug: Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 dose

    Determination of the recommended Phase 2 dose based on the safety of tagraxofusp in combination with cladribine and low-dose cyatarabine, as determined by DLT evaluation.

    Measured: up 2 years

Secondary outcomes (6)

  1. Overall response rate (ORR)

    ORR will be determined by the proportion of study subjects achieving Complete Remission (CR), Complete remission with incomplete hematologic recovery (CRi), Complete remission with partial hematologic recovery (CRh), Morphological leukemia-free state (MLFS), or (Partial Response (PR), as defined by the ELN 2022 AML response criteria.

    Measured: up 2 years

  2. Complete response

    Complete Response will be determined by the proportion of study subjects achieving CR, as defined by the ELN 2022 AML Response Criteria.

    Measured: up 2 years

  3. Composite complete response (CR+CRi +CRh)

    Composite complete response will be determined by the proportion of study subjects achieving CR, CRi, or CRh, as defined by the ELN 2022 AML Response Criteria.

    Measured: up 2 years

  4. Rate of Minimal Residual Disease (MRD) negativity in responders

    Rate of MRD negativity in responders, as measured by multi-parameter flow cytometry.

    Measured: up 2 years

  5. Duration of overall survival

    Overall survival (OS) will be measured as the date of enrollment in the study to the date of death from any cause.

    Measured: up 2 years

  6. Incidence of drug-related adverse events

    The Incidence of Drug-Related Adverse Events is a safety endpoint used to evaluate the frequency and severity of adverse events (AEs) that are attributed to the study drug All grades of adverse events determined to be treatment-related will be summarized descriptively.

    Measured: up 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start10 Feb 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561152
Sponsor's protocol ID
IRB-76512
Other IDs
NCI-2025-01963
Status last verified
Apr 2026
First submitted
16 Aug 2024
Last updated
14 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tagraxofusp, Cladribine (CLAD) and Cytarabine in people with Refractory Acute Myeloid Leukemia and Relapsed Acute Myeloid Leukemia, run by Stanford University 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 17 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: looking for participants now, as of the sponsor's last update on 14 Apr 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 combined 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.

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 Woo In (Yustina) Cho (650-721-2443, wooin@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 dose (time frame: up 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561152.

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 14 Apr 2026.

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