Tagraxofusp and Azacitidine for AML and MDS After Transplant
This study is testing a combination of two drugs, tagraxofusp and azacitidine, as a maintenance treatment for people with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that have a specific marker called CD123. This treatment is given after you've had a donor hematopoietic cell transplant (HCT), which is a type of transplant where you receive cells from another person. The goal of this maintenance treatment is to help prevent the cancer from coming back. Researchers want to find out if this combination is safe, what side effects it might cause, and how well it works. They are also looking for the best dose of tagraxofusp to use. You may be able to join if you are between 18 and 75 years old and meet other health criteria. The study aims to enroll 43 participants, but its current recruitment status is unclear.
- Study design
- This is a Phase Ib interventional study, meaning it's an early-stage trial looking at safety and dosage. It plans to enroll 43 participants.
- What's involved
- You would receive azacitidine intravenously (IV) and undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy. You would also complete questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your adverse events will be monitored for up to 30 days after your last dose of study treatment. Researchers will also track how many patients complete at least 3 cycles for up to 180 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06498973
Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant
Recruiting
PHASE1Ages 18–75InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~43 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:AzacitidineBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyQuestionnaire AdministrationTagraxofusp-erzs
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 30 days after last dose of study treatment
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Monzr M. Z Al Malki, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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
Documented informed consent of the participant and/or legally authorized representative
Agreement to allow the use of archival tissue from diagnostic tumor biopsies.
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: 18-75 years old
Eastern Cooperative Oncology Group (ECOG) ≤ 2
First or second allogeneic HCT-eligible patients with AML or MDS with high-risk cytogenetics per European LeukemiaNet (ELN) (AML) or Revised International Prognostic Scoring System (R-IPSS) (MDS); or by having active (morphological) or minimal residual disease (MRD)+ status at the time of HCT (by multicolor flowcytometry, cytogenetics or molecular testing) OR patients who underwent HCT for AML or MDS with high-risk cytogenetics per ELN (AML) or R-IPSS (MDS)
Positive for CD123 by flow cytometry of either peripheral blood or bone marrow aspirates at the time of diagnosis at any time-point prior to HCT. (Note: CD123 measurement will be conducted using the 10-color Beckman Coulter Navios XL flow cytometer. We will use CD123 PE \[Beckman Coulter #A32535\] to gate the abnormal population of interest. This population will be compared to the internal negative control population \[e.g., T-cells\]. If more than 20% of the abnormal population is positive relative to this control, it will be classified as positive.)
Any conditioning regiment or GVHD prophylaxis is allowed
Any donor (i.e., match related/unrelated, mismatched, haploidentical, etc.) or graft source (i.e., bone marrow, mobilized peripheral blood stem cells, etc.) is allowed
Prior treatment with CD123-therapy is allowed if no progression is documented on therapy
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
STUDY MAINTENANCE TREATMENT: Complete response (CR) or MRD-positive on day 30 bone marrow biopsy (BMB) for disease assessment
STUDY MAINTENANCE TREATMENT: Patients must be fully engrafted after HCT before starting the first cycle of maintenance. Full engraftment is defined as absolute neutrophil count (ANC) of 500 or above for 3 days and platelet count of more than 20,000 without transfusion for 7 consecutive days
STUDY MAINTENANCE TREATMENT: ECOG ≤ 2
STUDY MAINTENANCE TREATMENT: No treatment with anti-CD123 therapy after allogeneic HCT
STUDY MAINTENANCE TREATMENT: No evidence of active or uncontrolled infection
STUDY MAINTENANCE TREATMENT: No active GVHD; prednisone dose of ≤ 10 mg/daily is allowed
STUDY MAINTENANCE TREATMENT: ANC ≥ 1.5 (within 7 days of day 1 of the cycle 1)
NOTE: Transfusion (red blood cells \[RBC\] or platelet) to achieve the above-mentioned counts is allowed
STUDY MAINTENANCE TREATMENT: Hemoglobin (HbG) ≥ 7 (within 7 days of day 1 of the cycle 1)
NOTE: Transfusion (RBC or platelet) to achieve the above-mentioned counts is allowed
STUDY MAINTENANCE TREATMENT: Platelet count ≥ 20K (within 7 days of day 1 of the cycle 1)
NOTE: Transfusion (RBC or platelet) to achieve the above-mentioned counts is allowed
STUDY MAINTENANCE TREATMENT: Total bilirubin ≤ 2 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 7 days of day 1 of the cycle 1)
STUDY MAINTENANCE TREATMENT: Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 7 days of day 1 of the cycle 1)
STUDY MAINTENANCE TREATMENT: Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 7 days of day 1 of the cycle 1)
STUDY MAINTENANCE TREATMENT: Serum albumin \> 3.2 (within 7 days of day 1 of the cycle 1) (note that albumin infusions are not permitted in order to enable eligibility but can be given after treatment starts)
STUDY MAINTENANCE TREATMENT: Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 7 days of day 1 of the cycle 1)
STUDY MAINTENANCE TREATMENT: If not receiving anticoagulants: International normalized ratio (INR) or prothrombin (PT) ≤ 1.5 x ULN (within 7 days of day 1 of the cycle 1)
If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
STUDY MAINTENANCE TREATMENT: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 7 days of day 1 of the cycle 1)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
STUDY MAINTENANCE TREATMENT: The Patient should agree to use acceptable contraceptive methods for the duration of the time in the study, and to continue to use contraceptive methods for 6 months following the end of study therapy
STUDY MAINTENANCE TREATMENT: The patient may not have persistent clinically significant toxicities grade ≥ 1 from previous therapies, including cytotoxic chemotherapy, targeted therapies, biological therapies, or immunotherapies, not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue)
STUDY MAINTENANCE TREATMENT: The patient has not received treatment with another investigational agent within 14 days of study entry
STUDY MAINTENANCE TREATMENT: The patient does not have 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)
STUDY MAINTENANCE TREATMENT: The patient does not have 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
STUDY MAINTENANCE TREATMENT: The patient does not have known active or suspected central nervous system (CNS) disease. If suspected, CNS disease should be ruled out with relevant imaging and/or examination of cerebrospinal fluid
STUDY MAINTENANCE TREATMENT: The patient does not have 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
STUDY MAINTENANCE TREATMENT: The patient does not have any condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities
Exclusion
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (tagraxofusp and azacitidine)
Females only: Pregnant or breastfeeding
Any other condition including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness, that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
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 has known active or suspected central nervous system (CNS) disease. If suspected, CNS disease should be ruled out with relevant imaging and/or examination of cerebrospinal fluid
Active hepatitis B or C or HIV infection
The patient has any condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Incidence of adverse events (AEs)Up to 30 days after last dose of study treatment
Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. AEs will be recorded by type, severity, duration, and attribution or association with the study regimen and occurrence. Tables will be constructed to summarize the observed incidence, severity and type of toxicity. Point estimates and corresponding exact 95% confidence intervals (CIs) will be provided for each measure of toxicity/AEs.
- Dose limiting toxicities (DLT)Up to the end of cycle 1 on day 28
DLTs will be graded according to the NCI CTCAE v5.0. AEs will be recorded by type, severity, duration, and attribution or association with the study regimen and occurrence. Tables will be constructed to summarize the observed incidence, severity and type of toxicity. Point estimates and corresponding exact 95% CIs will be provided for each measure of toxicity/AEs.
- Percent of patients completing at least 3 cycles at assigned dose levelUp to 180 days
Feasibility will be defined as 50% of patients completing at least 3 cycles of maintenance therapy at the assigned dose level. The point estimate and exact 95% CIs will be provided.