Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT03514017
- Brief 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 CLL patients. Immune function will be evaluated through various laboratory correlative tests.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pembrolizumab and Ibrutinib 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 and Ibrutinib Pembrolizumab 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.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) to the Therapeutic Intervention Up to 2 years Response categories according to The International Workshop on Chronic Lymphocytic Leukemia (IWCLL): Complete remission (CR); Complete remission with incomplete marrow recovery (CRi); Partial remission (PR); Progressive disease (PD); Stable disease (SD), defined as not meeting criteria for CR, CRi, PR or PD.
Time to Best Response Up to 2 years Time to best response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) Up to 2 years Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to \> 5 x10\^9/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL.
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States