Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
Stopped early · Phase 2
Conditions studied: Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT03514017
- Run by
- H. Lee Moffitt Cancer Center and Research Institute
- People needed
- 5
- Starts
- 2019-05-31
- Expected to finish
- 2023-05-16
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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