Chronic Lymphocytic Leukemia Clinical Trial
Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
The purpose of this study is to evaluate the impact of sequential overlapping treatment with PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous immune function in previously untreated, high-risk leukemia-cll/" >CLL patients. Immune function will be evaluated through various laboratory correlative tests.
Have high risk CLL
Have documented previously untreated CLL according to IWCLL criteria
Willing and able to provide written informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Demonstrate adequate organ function
Able to take oral medication and willing to adhere to the medication regimen
Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
Meets IWCLL criteria to start therapy
Has had any treatment for CLL including any investigational agent, chemotherapy, mAb, anti-PD-1, anti-PDL-1, or anti-CTLA-4
Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia)
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment
Major surgery or a wound that has not fully healed within 4 weeks of first dose
Additional criteria may apply
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There is 1 Location for this study
Tampa Florida, 33612, United States
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