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 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT02328950
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* Aged between 0-65 years
* Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1
* Patients with advanced MDS
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%
Exclusion Criteria:
* Pregnant or lactating females
* Current participation in another clinical trial
* Contra-indication to one of the drug of the regimen
* Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
65 Years
Study:
NCT02328950
Study Brief:
Protocol Section:
NCT02328950