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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT04562792
Eligibility Criteria:
Inclusion Criteria:
* Patients with pathologically confirmed ALL or AML, whose disease is refractory to two induction therapeutic attempts, or who are in 2nd or greater relapse, or who are in 1st relapse or refractory to a single therapeutic attempt but are unable to receive intensive therapy at the time of consent.
* All prior upfront therapies including bone marrow transplant are acceptable. Pulse steroids (of 5 days duration or less in the prior month) administered as part of a routine maintenance therapy are acceptable.
* Age 1 to 21 years of age, inclusive
* Established central catheter IV access
Exclusion Criteria:
* Females who are known to be pregnant or lactating
* Any Grade 3 or higher Cardiac Disorder per CTCAE version 5
* Patients with echocardiographic evidence of cardiomyopathy (shortening fraction \<27% or ejection fraction \<50%)
* Uncontrolled sepsis
* Absolute Blast Count \>50 x10(3)/mcL at enrollment or on day 1 of study
* Direct hyperbilirubinemia \>5mg/dL
* Grade 3 or higher anaphylaxis to daunorubicin
* Non-English speaking
* Patients, who in the opinion of the PI, are unable to tolerate any study-specific procedures
* Patients who have received cyclosporine, tacrolimus or other agents to prevent or treat graft-vs-host disease post bone marrow transplant in the last 14 days
* Concurrent investigational drugs or other chemotherapeutic agents (excluding hydroxyurea), immunotherapies or biosimilars during the 5 days of daunorubicin.
* Prior cumulative doses of anthracyclines will not be an exclusion regardless of the total cumulative dose previously received.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT04562792
Study Brief:
Protocol Section:
NCT04562792