Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT05506956
Eligibility Criteria:
Inclusion Criteria:
1. A confirmed prior diagnosis of AML and underwent an alloHSCT as a form of consolidation in a morphologic complete remission
2. ECOG performance status 0-2
3. Ability to give informed consent
4. In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
5. Age ≥18 years
6. Prior treatment with a CD123-targeted therapy will be allowed assuming the patient did not have a grade 3 or 4 adverse reaction to prior use of this treatment
7. Normal thyroid function (defined by either a thyroid-stimulating hormone (TSH) within the reference range, a TSH above the reference range with a free T4 within the reference range, or a TSH below the reference range with both a free T4 and total T3 within the reference range) or normal thyroid tests on supplementation or treatment (defined as a TSH within the reference range)
8. Patients should be at least 30 days from transplant with morphologic evidence of disease progression on bone marrow biopsy
9. The presence of a CD123+ AML must be confirmed by flow cytometry with \>1% CD123 AML blasts
10. Peripheral blast count ≤20,000/mm3 at time of initiation on Cycle 1 Day 1
Exclusion Criteria:
1. No evidence of donor engraftment (100% patient DNA in bone marrow or peripheral blood after alloHSCT based on either an unsorted specimen or CD3 sorted).
2. Active AML in central nervous system (CNS) or testes
3. Patients with active, uncontrolled infection. If an infection is controlled and under treatment, then the patient may become eligible.
4. Patients with active acute or chronic GVHD requiring GVHD therapy (mycophenolate mofetil, tacrolimus, sirolimus, or steroids) within 30 days
5. Patients without active acute or chronic GVHD requiring prophylactic GVHD therapy (mycophenolate mofetil, tacrolimus, sirolimus, or steroids) within 30 days
6. Inadequate end organ function defined as:
* Hepatic-AST, ALT, and alkaline phosphatase \> 3.5X upper limit of normal (ULN), bilirubin \>2.5X ULN
* Renal-creatinine clearance \<60 mL/min using the modified Cockcroft-Gault formula
* Cardiac-Recent myocardial infarction within 6 months, Congestive Heart Failure with ejection fraction (EF) \<50%, active pericarditis or myocarditis
* Pulmonary-Need for supplemental oxygen to maintain oxygen saturation \>92%
* Adrenal-Adrenal insufficiency requiring physiologically-dosed steroids
7. Women who are pregnant or lactating
8. Previous or known hypersensitivity to biological agents or constituents of flotetuzumab or its source material
9. Concurrent use of any other investigational drugs
10. Uncontrolled infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus (HCV)
11. Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically with stable supplementation)
12. Previous treatment with radiotherapy or an immunotherapeutic agent in the 14 days prior to study drug administration (Cycle 1 Day 1) or 5 half-lifes, whichever is longer
13. Requirement, at the time of study entry, for concurrent steroids \> 10 mg/day of oral prednisone or equivalent, except steroid inhaler, nasal spray, or ophthalmic solution
14. Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to study drug administration
15. Prior adverse event with CD123 therapy necessitating therapy discontinuation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05506956
Study Brief:
Protocol Section:
NCT05506956