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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT05662904
Eligibility Criteria:
Key Inclusion Criteria:
* confirmed AML according to the WHO classification
* relapsed disease after allo-SCT from an HLA-identical family donor (≥ 2 months after allo-SCT at time of inclusion)
* ≤ 29% of bone marrow blasts as detected by cytomorphology or immunohistochemistry
* age ≥ 18 years
* confirmed CD33 expression on leukemic blasts at current relapse (as detected by flow cytometry)
* adequate organ function:
* Renal function defined as: serum creatinine of ≤ 2x ULN or eGFR ≥ 30 mL/min/1.73 m2
* Liver function defined as:
* ALT ≤ 3 times the ULN for the respective age
* Bilirubin ≤ 2.0 mg/dl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia)
* Minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \> 90% on room air
* Hemodynamic stability and LVEF ≥ 40% as confirmed by echocardiogram
* Absolute lymphocyte count (ALC) ≥ 100/mm3
Key Exclusion Criteria:
* ECOG performance status \>2
* Confirmed CNS involvement
* Acute or chronic Graft versus Host disease (GvHD)
* Availability of other curative standard treatment options
* Prior treatment with GO
* Prior hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
* Uncontrolled active hepatitis B or C
* HIV-positivity
* Uncontrolled bacterial, viral or fungal infection
* Participation in another clinical trial at the time of screening
* Organ dysfunction (liver, kidney, lung, heart) that is a contraindication for conditioning therapy
* Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure NYHA III-IV, uncontrolled diabetes mellitus, uncontrolled hyperlipidemia)
* Unstable angina and/or myocardial infarction within 3 months prior to screening
* Pregnant or nursing (lactating) women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05662904
Study Brief:
Protocol Section:
NCT05662904