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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT03989466
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of T-cell prolymphocytic leukemia (T-PLL) will be eligible (both treatment naïve and relapsed patients are eligible).
* Age \>/= 18 years.
* Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting ITACITINIB. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.
* Adequate organ function as defined below: liver function (bilirubin \</=2mg/dL, AST and ALT \</=3 x ULN or \</=5 x ULN if related to leukemic involvement); kidney function (estimated creatinine clearance \> 50); known cardiac ejection fraction of \> or = 45% within the past 3 months; and platelet count \</=30,000.
* ECOG performance status of \</= 2.
* A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
Exclusion Criteria:
* Patients with a diagnosis of T-cell prolymphocytic leukemia (T-PLL) will be eligible (both treatment naïve and relapsed patients are eligible).
* Age \>/= 18 years.
* Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting ITACITINIB. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.
* Adequate organ function as defined below: liver function (bilirubin \</=2mg/dL, AST and ALT \</=3 x ULN or \</=5 x ULN if related to leukemic involvement); kidney function (estimated creatinine clearance \> 50); known cardiac ejection fraction of \> or = 45% within the past 3 months; and platelet count \</=30,000.
* ECOG performance status of \</= 2.
* A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03989466
Study Brief:
Protocol Section:
NCT03989466