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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT04240704
Eligibility Criteria:
Inclusion Criteria:
For patients with CLL:
• Confirmed diagnosis of chronic lymphocytic leukemia (CLL)
For patients with NHL:
* Histologically confirmed diagnosis of B- or T-cell non-Hodgkins lymphoma (NHL).
* Must have a site of disease amenable to biopsy, and be suitable and willing to undergo study required biopsies at screening and during therapy.
Exclusion Criteria, applicable to both CLL and NHL:
* History of anaphylactic or other severe hypersensitivity/infusion reactions to ADCs, monoclonal antibodies (mAbs) and/or their excipients such that the patient in unable to tolerate immunoglobulin/monoclonal antibody administration
* Any prior history of treatment with maytansine (DM1 or DM4)-based ADC
* Known intolerance to a maytansinoid
* Patients with any active or chronic corneal disorders
* Patients who have any other condition that precludes monitoring of the retina or fundus
* Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was completed \>4 weeks before first dose of study treatment. Patients that have been effectively treated for CNS disease and are stable under systemic therapy may be enrolled provided all other inclusion and exclusion criteria are met. Patients who received prophylactic intrathecal treatment are eligible, if treatment discontinued \>5 half-lives prior to the first dose of study treatment
* Impaired cardiac function or clinically significant cardiac disease
* Known history of Human Immunodeficiency Virus (HIV) infection
* Active HBV or HCV infection. Patients whose disease is controlled under antiviral therapy should not be excluded. Patients who are anti-HBcAb positive should be HBsAg negative and HBV-DNA negative to be eligible
Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04240704
Study Brief:
Protocol Section:
NCT04240704