Can a Drug-Vaccine combo delay leukemia in High-Risk patients?
NCT ID NCT02518555
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested whether giving the targeted drug ibrutinib along with standard vaccines (pneumonia, flu, and Tdap) can help people with early-stage, high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) stay progression-free longer. The study enrolled 42 asymptomatic patients with high-risk genetic features. The goal was to see if early intervention could delay the need for stronger treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ibrutinib (a targeted cancer drug) and vaccines (pneumococcal, influenza, and Tdap)
- What this could lead to
- If successful, this could show that early use of ibrutinib with vaccines delays disease progression in high-risk CLL/SLL patients who are not yet sick.
- What could go wrong
- This is a small, early-phase trial (42 participants) with no control group for comparison. Ibrutinib has side effects like bleeding and infection risk, and the vaccines may not boost immunity as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
42 people
The number who actually took part.
- Started
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Jan 2016
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms * CLL/SLL cells must demonstrate one or more of the following high-risk genomic features: * Del17p13.1(tumor protein p53 \[TP53\]) as detected by fluorescence in-situ hybridization (FISH) * Del11q22.3 ataxia telangiectasia mutated (ATM) as detected by FISH * Complex karyotype (\>= 3 cytogenetic abnormalities on stimulated karyotype) * Unmutated immunoglobulin variable region heavy chain (IgVH) ( \>= 98% sequence homology compared with germline sequence) * Zeta-chain (TCR) associated protein kinase 70kDa (ZAP-70) gene promoter hypomethylation \< 20% * No prior therapy for CLL/SLL, including chemotherapy and/or radiotherapy is allowed * Estimated life expectancy of greater than 24 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Total bilirubin =\< 1.5X upper limit of normal (ULN) unless secondary to Gilbert's disease * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5X institutional upper limit of normal * Serum creatinine =\< 2 md/dL or estimated creatinine clearance (CrCl) \> 50ml/min/body surface area (BSA) * Prothrombin time (PT)/international normalized ratio (INR) \< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time \[aPTT\]) \< 1.5 x ULN * Able to swallow capsules without difficulty and no history of malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or active ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction * Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for \>= 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy); female subjects of childbearing potential must have a negative serum pregnancy test upon study entry * Male and female subjects who agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices \[IUDs\], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug Exclusion Criteria: * Patients meeting any of the following consensus criteria for initiating treatment for their CLL: * Progressive symptomatic splenomegaly and/or lymphadenopathy identified by physical examination * Anemia ( \< 11g/dL) or thrombocytopenia ( \< 100,000/uL) due to bone marrow involvement * Presence of unintentional weight loss \> 10% over the preceding 6 months * National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade \>= 3 fatigue * Fevers \> 100.5°F or night sweats for \> 2 weeks without evidence of infection * Patients who have had any treatment for their CLL/SLL, including but not limited to chemotherapy, radiotherapy, or immunotherapy, prior to entering the study * No corticosteroid use will be permitted within two weeks prior to study, except for maintenance therapy for a non-malignant disease; maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent * Patients may not be receiving any other investigational agents * History of allergic reactions attributable to compounds of similar chemical or biologic composition to ibrutinib or any component of pneumococcal, influenza and DTaP vaccines * Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject is considered by his or her physician to have a less than 2-year survival expectation * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and/or psychiatric illness/social situations that would limit compliance with study requirements * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization * Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration \[\> 14 days\] of \> 20mg/day of prednisone) within 14 days of the first dose of study drug * Patients must discontinue treatment with H2-blockers (cimetidine, ranitidine, etc.) prior to beginning protocol therapy * Vaccinated with any of the vaccines planned for administration in the trial within 8 weeks of starting treatment on the study * Recent infection requiring systemic treatment that was completed =\< 14 days before starting treatment on the study * Concomitant use of warfarin or other vitamin K antagonists * Patients who require treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor * Known bleeding disorders (eg, von Willebrand's disease) or hemophilia * History of stroke or intracranial hemorrhage within 6 months prior to enrollment * Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV); patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded * Major surgery within 4 weeks of starting trial * Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk * Lactating or pregnant * Unwilling or unable to participate in all required study evaluations and procedures * Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a triple drug combo outsmart High-Risk CLL?