Phase 2
N=35
Ibrutinib in Treating Minimal Residual Disease in Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy
Stage I Chronic Lymphocytic Leukemia · Stage II Chronic Lymphocytic Leukemia · Stage III Chronic Lymphocytic Leukemia · Stage IV Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02649387 ↗Enrolled (actual)
35
Serious AEs
45.7%
Results posted
Jul 2025
Primary outcome: Primary: Rate of Confirmed MRD-negative Response — 0 proportion of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibrutinib (Drug); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Confirmed MRD-negative Response |
— | — |
| SECONDARY Duration of MRD-negative Response |
— | — |
| SECONDARY Improvement in Clinical Response |
— | — |
| SECONDARY Incidence of Adverse Events |
— | — |
| SECONDARY Progression-free Survival |
— | — |
| SECONDARY Time to MRD-negative Response |
— | — |
| SECONDARY Time to Requirement of Next Therapy |
— | — |
Summary
This phase II trial studies the side effects and how well ibrutinib works in treating patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Understand and voluntarily sign an informed consent form
- Able to adhere to the study visit schedule and other protocol requirements including willing to provide blood, baseline bone marrow aspirate, and control deoxyribonucleic acid (DNA) samples for correlative research purposes
- Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL), confirmed by flow cytometry and as per the criteria outlined by the IWCLL/Hallek December 2008
- Prior frontline therapy for B-CLL must have been discontinued >= 56 days but = = 1 CLL cell per 10,000 leukocytes or >= 0.01% MRD) either in the blood, bone marrow or a lymph node >= 3.5 cm by any available techniques
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at registration
- Absolute neutrophil count >= 1000/mm^3
- Platelet count >= 30,000/mm^3
- Serum creatinine = 3 years)
- Patients who are already MRD- (both in the blood and the bone marrow) after frontline therapy and have lymph nodes < 3.5 cm
- Concomitant use of warfarin or other vitamin K antagonists
- Requires treatment with a strong cytochrome P450 modulators (cytochrome P450, family 3, subfamily A [CYP3A] inhibitor and/or CYP3A inducers)
- Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
- Major surgery =< 4 weeks prior to registration
- Patients who have active infectious hepatitis
- Patients with other diseases that in the opinion of the treating physician pose a higher risk for treatment with ibrutinib therapy including active human immunodeficiency virus (HIV) infection and bleeding disorders
Data sourced from ClinicalTrials.gov (NCT02649387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.