Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

  • End date
    Dec 14, 2023
  • participants needed
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 14 August 2021
lymphoid leukemia
monoclonal antibodies
monoclonal protein


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 CLL patients. Immune function will be evaluated through various laboratory correlative tests.

Condition Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma
Treatment Ibrutinib, Pembrolizumab
Clinical Study IdentifierNCT03514017
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on14 August 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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