Clinical trial · Interventional
Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Dysfunction
NCT03514017CI-TRIAL-00104364terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding unavailable
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pembrolizumab and Ibrutinib
- description
- 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.
- interventionNames
- Drug: Pembrolizumab
- Drug: Ibrutinib
Primary outcomes (2)
- measure
- Overall Response Rate (ORR) to the Therapeutic Intervention
- timeFrame
- Up to 2 years
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.