Actively Recruiting
Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant
Led by City of Hope Medical Center · Updated on 2026-03-05
43
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase Ib trial tests the safety, side effects, best dose and effectiveness of tagraxofusp in combination with azacitidine as maintenance therapy in treating patients with CD123 positive acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after a donor (allogeneic) hematopoietic cell transplant. An allogeneic hematopoietic cell transplant (HCT) is a type of transplant where the cancer patient receives cells from another person. Maintenance therapy is given after the transplant to prevent the cancer from coming back. Tagraxofusp is a drug that targets cells that have CD123 on their surface in order to kill the cancer cells to help prevent the cancer from coming back. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Giving tagraxofusp in combination with azacitidine may be safe, tolerable and/or effective maintenance therapy in patients with CD123 positive AML and MDS after an allogeneic HCT.
CONDITIONS
Official Title
Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent
- Agree to allow use of archival tissue from diagnostic tumor biopsies or get PI approval if unavailable
- Age between 18 and 75 years
- ECOG performance status of 2 or less
- First or second allogeneic HCT-eligible patients with AML or MDS with high-risk cytogenetics or active/minimal residual disease at time of HCT
- Positive for CD123 by flow cytometry on blood or bone marrow at any time before HCT
- Any conditioning regimen or GVHD prophylaxis allowed
- Any donor or graft source allowed
- Prior CD123 therapy allowed if no disease progression on it
- Agree to use effective birth control or abstain during study and 6 months after last dose if of childbearing potential
- Complete response or MRD-positive on day 30 bone marrow biopsy
- Fully engrafted after HCT with ANC ≥500 for 3 days and platelets >20,000 without transfusion for 7 days
- ECOG status ≤2 at maintenance treatment start
- No anti-CD123 therapy after allogeneic HCT
- No active or uncontrolled infection
- No active GVHD; prednisone ≤10 mg daily allowed
- ANC ≥1.5 within 7 days before cycle 1 day 1 (transfusions allowed)
- Hemoglobin ≥7 within 7 days before cycle 1 day 1 (transfusions allowed)
- Platelet count ≥20,000 within 7 days before cycle 1 day 1 (transfusions allowed)
- Total bilirubin ≤2x upper limit normal unless Gilbert's disease within 7 days before cycle 1 day 1
- AST and ALT ≤2.5x upper limit normal within 7 days before cycle 1 day 1
- Serum albumin >3.2 within 7 days before cycle 1 day 1
- Creatinine clearance ≥30 mL/min within 7 days before cycle 1 day 1
- INR/PT ≤1.5x upper limit normal or within therapeutic range if on anticoagulants within 7 days before cycle 1 day 1
- Negative pregnancy test for women of childbearing potential within 7 days before cycle 1 day 1
- Agree to continue contraception during study and for 6 months after
- No persistent grade ≥1 toxicities from prior therapies except alopecia, nausea, fatigue
- No treatment with other investigational agents within 14 days before study entry
- No clinically significant cardiovascular disease
- No uncontrolled clinically significant pulmonary disease
- No known active or suspected CNS disease
- No uncontrolled intercurrent illness or psychiatric/social issues limiting compliance
- No conditions placing patient at unacceptable risk for toxicities
You will not qualify if you...
- History of allergic reactions to tagraxofusp, azacitidine, or similar compounds
- Pregnant or breastfeeding women
- Conditions contraindicating study participation due to safety concerns including uncontrolled infection or psychiatric illness
- Active malignancy or cancer history that may affect study assessments except specific low-risk cancers
- Clinically significant cardiovascular disease such as recent heart failure, angina, myocardial infarction, stroke, uncontrolled hypertension, or arrhythmias
- Uncontrolled significant pulmonary disease
- Known active or suspected CNS disease
- Active hepatitis B, hepatitis C, or HIV infection
- Any condition placing patient at unacceptable risk for toxicities
- Inability to comply with study procedures due to feasibility or logistics issues
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
Research Team
H
Hoda Pourhassan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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