Chronic Lymphocytic Leukemia Clinical Trial

Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT03514017

Recruitment Status:

Suspended

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There is 1 Location for this study

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H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT03514017

Recruitment Status:

Suspended

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

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