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 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT00909168
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 years.
* WHO PS grade 0-2 (Appendix B) or Karnofsky \> 70.
* AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should be assessed on a BM aspiration or on a BM biopsy
* All FAB subtypes except M3.
* CD33 positivity (\> 20%). It is mandatory to perform an immunotyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor.
* Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML (including AML after MDS).
* Adequate renal and liver function, i.e., creatinine \< 2 mg/dl and bilirubin, ALT/AST ≤ 3 times the upper limit of normal.
* Written informed consent
Exclusion Criteria:
* Blast crisis of chronic myeloid leukemia.
* AML supervening after other myeloproliferative diseases.
* AML de novo or secondary previously pretreated.
* Concomitant malignant disease.
* Active central nervous system (CNS) leukemia.
* Active uncontrolled infection \[NB severe systemic infection should be excluded\].
* Concomitant severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease.
* Cardiac ejection fraction of 50% or less.
* Severe pulmonary dysfunction (CTC grade 3-4).
* Severe concomitant neurological or psychiatric disease.
* History of alcohol abuse.
* HIV positivity.
* Pregnancy.
* Man and woman not agreeing to the adequate contraceptive precautions during study period and for at last 24 months after stop of therapy.
* Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00909168
Study Brief:
Protocol Section:
NCT00909168