Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03514017
• Other study ID #: MCC-19199
• Status: Terminated
• Phase: Phase 2
• Start date: May 31, 2019
• Est. completion date: May 16, 2023

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Janssen Scientific Affairs, LLC, Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) to the Therapeutic Intervention	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.	Up to 2 years
Primary	Time to Best Response	Time to best response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention.	Up to 2 years
Secondary	Progression-free Survival (PFS)	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.	Up to 2 years

External Links

•   Moffitt Cancer Center Clinical Trials website