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:
NCT06133556
Eligibility Criteria:
Inclusion Criteria:
* Refractory / relapsed AML.
* Patients with a HLA matched related or unrelated donor (9\~10/10) or haplo-identical related donor, plan to receive HSCT.
* Age ≤ 60 years old, men and women are not limited.
* The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.
* Informed consent must be signed before the start of the study procedure. Informed consent must be signed by the patient or his or her immediate family members who are 18 years of age or older ; informed consent was signed by the legal guardian for children and adolescent patients under 18 years old. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.
Exclusion Criteria:
* Have a history of cancer and have received any treatment for this tumor in the past 3 years. But remove superficial bladder cancer, skin basal cells or squamous cell carcinoma, cervical epithelium. Intraepithelial neoplasia ( CIN ) or prostatic intraepithelial neoplasia ( PIN ).
* MPAL.
* It is known that the serological reaction of HIV or active hepatitis C virus is positive.
* The inability to cooperate with the requirements of research, treatment and monitoring due to mental illness or other conditions.
* Pregnant patients or patients who could not take appropriate contraceptive measures during treatment.
* Previously received hematopoietic stem cell transplantation.
* Active heart disease, defined as one or more of the following :
1. ) Uncontrolled or symptomatic angina history.
2. ) Myocardial infarction less than 6 months away from the study.
3. ) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms.
4. ) Uncontrolled or symptomatic congestive heart failure ( \> NYHA class 2 ).
5. ) The ejection fraction is lower than the lower limit of the normal range.
* Researchers evaluated that is not suitable for the group.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
60 Years
Study:
NCT06133556
Study Brief:
Protocol Section:
NCT06133556