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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT04243434
Eligibility Criteria:
Key Inclusion Criteria:
* Patient has a hematological malignancy and is eligible to receive CHOP or R-CHOP regimen.
* Patient must have adequate hematological, renal, and hepatic function as specified below within 30 days prior to the first dose of study treatment:
* Patient has a left ventricular ejection fraction ≥50% by multigated acquisition scan or echocardiogram within 30 days prior to the first dose of study treatment.
Key Exclusion Criteria:
* Patient has severe neurologic disorders (Grade 3 and above) including peripheral motor and sensory, central and autonomic neuropathy.
* Patient has a history of persistent active neurologic disorders including the demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.
* Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
* Patient has bowel obstruction, paralytic ileus, or uncontrolled chronic constipation.
* Patient has severe, active and uncontrolled hepatic disease or dysfunction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04243434
Study Brief:
Protocol Section:
NCT04243434