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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT03964259
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of lymphoma or acute lymphoblastic leukemia
* Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
* Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
* Patients of childbearing potential must have a negative pregnancy test (serum or urine)
* Lactating female patients must agree not to nurse a child while on this trial
* All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable
Exclusion Criteria:
* Trisomy 21
* History of dialysis within 30 days prior to study registration or currently on dialysis
* Polyuric renal dysfunction
* Pregnancy
* Known or suspected pleural effusion
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT03964259
Study Brief:
Protocol Section:
NCT03964259