Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
NCT ID: NCT03514017
Last Updated: 2025-12-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2019-05-31
2023-05-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pembrolizumab and Ibrutinib
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Pembrolizumab
Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib
Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
Interventions
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Pembrolizumab
Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib
Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Janssen Scientific Affairs, LLC
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Julio Chavez, M.D.
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Moffitt Cancer Center Clinical Trials website
Other Identifiers
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MCC-19199
Identifier Type: -
Identifier Source: org_study_id