Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax for AML
This study is testing a combination of three drugs: Tagraxofusp, Azacitidine, and Venetoclax, for people with Acute Myeloid Leukemia (AML). The goal is to see if this combination can safely control any remaining leukemia cells that are not easily seen, which could help prevent the cancer from coming back. You might be able to join if you are 18 or older, have been diagnosed with AML, and have very few leukemia cells in your bone marrow. The study will look at how safe the drug combination is and how well it reduces these remaining leukemia cells. The current recruitment status is unclear.
- Study design
- This is a Phase 1/2, single-arm, multi-center, open-label study with a planned enrollment of 31 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes up to 28 days for safety and up to 4 months for measurable residual disease conversion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07148180
A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax
Recruiting
PHASE1Ages 18+InterventionalTreatmentJacqueline Garcia, MDInvestigator-initiated
~31 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:TagraxofuspAzacitidine (AZA)Venetoclax
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended phase II dose (RP2D) of tagraxofusp in combination with fixed dose of Azacitidine and Venetoclax [Phase I]
Measured over Up to 28 days
+2 more outcomes measured
Conditions
Where it's being run
2 sites across 1 statesMassachusetts2
Study leadership
- Jacqueline Garcia, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥ 18 years.
History of known diagnosis of Acute Myeloid Leukemia (including de novo, secondary or AML arising from MDS).
Subjects must be in CR, CRi, or CRh with \<5% morphologic blasts in bone marrow
Any evidence of CD123+ by central assessment.
Participants must have measurable disease, defined as ≥ 0.1% by multiparametric flow cytometric assay as assessed by central laboratory
ECOG performance status ≤2 (see Appendix A).
Subjects must have adequate organ and marrow function as defined below:
total bilirubin ≤ 1.5 x institutional upper limit of normal unless due to Gilbert or non-hepatic in origin
AST(SGOT) and ALT(SGPT) ≤ 3.0 × institutional upper limit of normal
Creatinine clearance ≥ 45 ml/min GFR by MDRD
Albumin ≥ 3.2 g/dL
Left ventricular ejection fraction ≥ institutional lower limit of normal by MUGA or echocardiogram within 30 days of first protocol treatment. This can be locally assessed.
Pregnancy potential: Female subjects of childbearing potential must have negative results for pregnancy test. Females with reproductive potential are advised to use effective contraception during study treatment and for at least 6 months after last dose. Similarly, males with female partners of reproductive potential are advised to use effective contraception during treatment and for at least 3 months after the last dose. Men must agree to abstain from donating sperm.
Subject is able and willing to adhere to the study visit schedule and other protocol requirements
Exclusion
Prior treatment with CD123-targeted therapy
Known diagnosis of acute promyelocytic leukemia.
Subjects who received intensive anti-leukemic chemotherapy within 2 weeks from first dose of study. If on venetoclax, subjects must be off venetoclax for at least 5 days
Subjects pre-arranged for SCT are only excluded if it is imminent.
History of prior allogeneic stem cell transplant
Subject has uncontrolled, clinically significant pulmonary disease (e.g. COPD, pulmonary hypertension, etc.) that in the opinion of the Investigator would put the subject at significant risk for pulmonary complications during the study.
Subject has experienced Grade 3 or Grade 4 capillary leak syndrome (CLS) in the past for any reason
Subjects with known HBV and/or HCV infection must have undetectable viral load during screening (HBV and HCV testing are not required.) Participants with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.
Subjects with known HIV positivity are permitted provided they have undetectable viral load at the time of screening (HIV testing is not required).
Subject has a concurrent malignancy or prior malignancy within the 6-month period before screening. To be eligible, subjects must be in remission from the prior malignancy at least 6 months prior to screening and all treatment-related toxicities must have resolved to ≤ Grade 1 except for alopecia. Exceptions include adequately treated basal or squamous cell skin cancer, superficial bladder cancer, adequately treated carcinoma in situ of the cervix or uterus, or carcinoma in situ of the breast, previous malignancy confined and surgically resected (or successfully treated with other modalities) with curative intent, which are permissible for inclusion. Maintenance therapy, hormonal therapy, or steroid therapy for a well-controlled concurrent malignancy is allowed.
Subject has uncontrolled systemic fungal, bacterial, or viral infection, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antivirals, or antifungals, either IV or oral. However, subjects with controlled infection still requiring anti-infectives are eligible.
Subjects with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, that have New York Heart Association Functional Class III or IV symptoms.
Subject has evidence of ongoing alcohol or drug abuse
Subjects with known active/symptomatic CNS involvement. CNS prophylaxis allowed
Subjects receiving moderate or strong P450 3A (CYP3A) inducers within 7 days of start of study therapy. See Appendix B for examples
Subjects with uncontrolled intercurrent illness.
Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
grapefruit or grapefruit products
Seville oranges (including marmalade containing Seville oranges)
star fruit
Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with trial therapy, breastfeeding should be discontinued if the mother is treated on trial.
What this trial measures
- Recommended phase II dose (RP2D) of tagraxofusp in combination with fixed dose of Azacitidine and Venetoclax [Phase I]Up to 28 days
Definition of RP2D is outlined in protocol section 5.4.
- Number of Participants Experienced Dose-Limiting Toxicity (DLT) [Phase I]Up to 28 days
Definition of Dose Limiting Toxicity (DLT) is outlined in protocol section 5.4.
- Measurable Residual Disease (MRD) conversion rate [Phase II]Up to 4 months
MRD conversion rate is defined as the proportion of participants that achieve multi-parametric flow cytometry (MFC) MRD conversion (positive to negative) within the first four cycles of therapy. MRD negativity will be defined according to 2021 ELN MRD Working Party Consensus Guidelines and central lab MRD will be used to make this determination: CR with negative MFC-MRD negative refers to achievement of flow MRD negativity: MFC-MRD negative in bone marrow defined as \<0.1% (same as \<10\^-3).