Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
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ClinicalTrials.gov Identifier: NCT03514017 |
Recruitment Status :
Recruiting
First Posted : May 2, 2018
Last Update Posted : October 6, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Lymphocytic Leukemia | Drug: Pembrolizumab Drug: Ibrutinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Dysfunction |
Actual Study Start Date : | April 10, 2019 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: 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. |
Drug: Pembrolizumab
Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Other Name: Keytruda® Drug: 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 Name: Imbruvica® |
- Overall Response Rate (ORR) to the Therapeutic Intervention [ Time Frame: 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 Response [ Time Frame: Up to 2 years ]Time to response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention.
- Restoration of Immune Response [ Time Frame: Up to 2 years ]Restoration of immune response as measured by: Decreased markers of T-cell exhaustion; Increased of quantitative immunoglobulin levels and subtype.
- Progression-free Survival (PFS) [ Time Frame: 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.
- Incidence of Richter's Transformation [ Time Frame: Up to 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514017
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Elyse Turba 813-745-1706 elyse.turba@moffitt.org | |
Contact: Julio Chavez, M.D. 813-745-2069 julio.chavez@moffitt.org |
Principal Investigator: | Julio Chavez, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT03514017 |
Other Study ID Numbers: |
MCC-19199 |
First Posted: | May 2, 2018 Key Record Dates |
Last Update Posted: | October 6, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphocytic Leukemia CLL Blood disease |
White blood cells Bone marrow disease Immunotherapy |
Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |