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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT01734304
Eligibility Criteria:
Inclusion Criteria:
* Patients male or female, age ≥ 18 years, biological age ≤ 75 years
* Patients with AML of non-favorable risk profile or with AML and sole NPM1 mutation and confirmed increase of MRD load as detected by RQ-PCR (in two measurements at least four weeks apart)
* CR or CRi after intensive induction chemotherapy (TAD, HAM, sHAM, 3+7 anthracycline + cytarabine regimen, or equivalent)
* Negative HIV test, negative hepatitis B and C test
* Negative pregnancy test in women of childbearing potential
* Ability to understand and willingness to sign a written informed consent
Exclusion Criteria:
* Patients suitable for allogeneic HSCT (indication for allogeneic HSCT, adequate donor, no contraindication for allogeneic HSCT)
* Patients with AML with favorable risk profile:
* APL (AML M3)
* inv(16), t(16;16), or del(16) as sole anomaly
* t(8;21) as sole anomaly
* biallelic CEBPA mutation as sole anomaly
* NPM1 mutation as sole anomaly, unless with confirmed increase of MRD load
* Prior allogeneic HSCT
* Anemia (Hb \< 9,0 mg/dl)
* Leukopenia (\< 4,0 G/l)
* Transfusion refractory thrombocytopenia (\< 30 G/l platelets despite adequate number of transfusions)
* Active clinically relevant autoimmune disease
* Active immunodeficiency syndromes
* Known allergy to GM-CSF, TNF, IFN-γ, IL-4, IL-1 beta, PGE2, R848, Human AB Serum, DMSO, HSA
* Continuous therapy with corticosteroids or other immunosuppressive drugs during the trial
* Present substance abuse or any other factor that could limit the subject's ability to comply with study procedures
* Severe organ dysfunction:
* Creatinine \> 2,5 mg/ml
* Bilirubin \> 3,0 mg/ml
* ALAT and ASAT \> 3 x upper normal limit
* Respiratory insufficiency with pO2 \< 60 mmHg
* Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure \> grade II NYHA
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
* Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial
Exclusion criteria regarding special restrictions for females:
* Current or planned pregnancy or nursing women
* Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration and at least 3 months thereafter (such as oral, injectable, or im-plantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01734304
Study Brief:
Protocol Section:
NCT01734304