Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia (NCT03989466) | Clinical Trial Compass
CompletedPhase 1
Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia
United States15 participantsStarted 2020-01-15
Plain-language summary
This phase Ib trial studies the side effects and best dose of alemtuzumab when given together with itacitinib in treating patients with T-cell prolymphocytic leukemia. Itacitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with alemtuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving itacitinib and alemtuzumab may work better in treating patients with T-cell prolymphocytic leukemia compared to standard of care treatment.
Who can participate
Age range18 Years
SexALL
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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 prolife…