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:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT04401267
Eligibility Criteria:
Inclusion Criteria:
* Patient is being treated for newly diagnosed acute lymphoblastic leukemia or lymphoma (ALL) on the TOT17 protocol. Patients do not need to be hypertensive to enroll.
* Patient is 10 years of age or older at the time of enrollment on TOT17.
* Patient has completed ≤ 4 days of protocol therapy (patients are eligible on Day 4 of TOT17 therapy).
Exclusion Criteria:
* Moderate-severe renal dysfunction (glomerular filtration rate \<45 ml/min/1.73m2).
* Down's syndrome (germline Trisomy 21) or other syndrome resulting in growth delay or alterations in stature.
* Chronic inability to ambulate. Patients with limitations in movement due to acute complications of leukemia/lymphoma are not excluded.
* Permanent contraindication to MRI evaluation.
* Participants who are pregnant or lactating. Males or females of reproductive potential must agree to use effective contraception for the duration of study participation.
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT04401267
Study Brief:
Protocol Section:
NCT04401267