Chronic Lymphocytic LeukemiaPhase 2NCT02518555
Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study testing Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Ibrutinib and Laboratory Biomarker Analysis in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Jennifer Woyach at 1 site in United States.
Trial summary
This randomized phase II trial studies how well ibrutinib works when given together with vaccine therapies in treating patients without clinical signs or indications that raise the possibility of a particular disorder or dysfunction (asymptomatic) who have high-risk chronic lymphocytic leukemia or small lymphocytic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Ibrutinib and Laboratory Biomarker Analysis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2016to 5 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Early Intervention Trial of Ibrutinib for Patients With Asymptomatic, High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This randomized phase II trial studies how well ibrutinib works when given together with vaccine therapies in treating patients without clinical signs or indications that raise the possibility of a particular disorder or dysfunction (asymptomatic) who have high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Vaccines, such as pneumococcal 13-valent conjugate vaccine, trivalent influenza vaccine, and diphtheria toxoid/tetanus toxoid/acellular pertussis vaccine adsorbed, may help the body build an effective immune response to kill cancer cells. Giving ibrutinib together with vaccine therapies may be a better treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the 2-year progression-free survival of asymptomatic, high-risk genomic chronic lymphocytic leukemia (CLL) patients treated with ibrutinib.
SECONDARY OBJECTIVES:
- To determine whether concurrent administration of ibrutinib with 2 doses of the pneumococcal vaccine (pneumococcal 13-valent conjugate vaccine) does not negatively impact the immune response compared to those who receive the pneumococcal vaccination with sequential therapy.
II. To determine the safety and toxicity associated with administering ibrutinib to asymptomatic, high-risk genomic CLL patients.
III. To determine the response pattern (complete response [CR] minimal residual disease [MRD]-, CR, partial response [PR], PR with lymphocytosis, stable disease [SD]) in asymptomatic, genomic high-risk patients treated with ibrutinib.
VI. To determine changes in the stress, anxiety and depressive symptoms, and related quality of life indicators from patients treated with ibrutinib.
- Being tested
- Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Ibrutinib, Laboratory Biomarker Analysis, Pharmacological Study, Pneumococcal 13-valent Conjugate Vaccine
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine AdsorbedBiological
Also called Adacel, Daptacel, Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine, DTaP
Given IM
IbrutinibDrug
Also called PCI-32765
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
Pneumococcal 13-valent Conjugate VaccineBiological
Also called PCV13 Vaccine, Prevnar 13
Given IM
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Trivalent Influenza VaccineBiological
Also called Flu prevention, Flu prophylaxis, Flu shot, Flu vaccination
Given IM
| Study group | Role | What they receive |
|---|---|---|
| Arm A (concurrent vaccines and ibrutinib) | Experimental | Patients receive ibrutinib PO QD on days 1-28. Patients also receive pneumococcal 13-valent conjugate vaccine IM on day 1 of courses 3 and 5 and trivalent influenza vaccine IM and DTaP vaccine IM on day 1 of course 4. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Receives: Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed; Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Biological: Pneumococcal 13-valent Conjugate Vaccine; Other: Quality-of-Life Assessment; Biological: Trivalent Influenza Vaccine |
| Arm B (sequential vaccines and ibrutinib) | Experimental | Patients receive pneumococcal 13-valent conjugate vaccine IM on day 1 of courses 1 and 3 and trivalent influenza IM and DTaP vaccine IM on day 1 of course 2. Beginning in course 4, patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity. Receives: Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed; Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Biological: Pneumococcal 13-valent Conjugate Vaccine; Other: Quality-of-Life Assessment; Biological: Trivalent Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are alive and progression-free
Measured: At 2 years from the date of the first ibrutinib administration
Secondary outcomes (5)
Degree of response (CR MRD-,CR, PR, PR with lymphocytosis, and SD)
Will be summarized across and within cohorts. Will graphically evaluate differences between responders and non-responders in select pharmacodynamic markers across and within arms using side-by-side boxplots. Provided an appropriate number of responses, will fit logistic regression models, with response as the dependent variable, and may find correlations of moderate significance that will merit further research in future studies. Time to treatment failure will be defined as the date of first ibrutinib therapy until the date of next treatment, date of death, or date off-study if due to toxicity, whichever occurs first, censoring patients at last follow-up. Response will be characterized according to a slight modification of the 2008 International Workshop on CLL (IWCLL) guidelines for the diagnosis and treatment of CLL, which include clinical, hematologic, and bone marrow features
Measured: Up to 4 years
Incidence of adverse events, evaluated using the NCI CTCAE version 4.0
In general, the maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed by and across arms to determine toxicity patterns. Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The incidence of severe (grade 3+) adverse events or toxicities will be described and reasons patients discontinue study treatment will be summarized.
Measured: Up to 30 days after study treatment
Proportion of patients who achieve complete response
CR requires following for period of at least 2 months while during therapy:
- Absence of adenopathy, hepatomegaly or splenomegaly on PE
- Absence constitutional symptoms
- Normal CBC as exhibited by polymorphonuclear leukocytes ≥ 1500/μL, PLT > 100,000/μL, HGB > 11.0 g/dL (untransfused), and lymphocyte count < 4,000/ μL. Achieve clinical CR lasting for at least 2 months will undergo radiologic eval by CT scans of chest, abd and pelvis. Patients who have radiologic evidence of CR (including absence of lymphadenopathy <1.5cm, absence of hepatomegaly and splenomegaly) will undergo bone marrow aspirate and biopsy
- Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules absent. Patients who fulfill criteria for CR with exception of having bone marrow lymphoid nodules will be considered a PR
- 5 color flow cytometry will be used to characterize min. residual dis
Measured: Within 2 years of starting ibrutinib treatment
Time to next treatment
Will be described across both cohorts by the Kaplan-Meier method.
Measured: Date of first ibrutinib therapy until the date of next treatment, assessed up to 4 years
Time to treatment failure
Time to treatment failure will be defined as the date of first ibrutinib therapy until the date of next treatment, date of death, or date off-study if due to toxicity, whichever occurs first, censoring patients at last follow-up. Time to treatment failure will be described across both cohorts by the Kaplan-Meier method.
Measured: Date of first ibrutinib therapy until the date of next treatment, date of death, or date off-study if due to toxicity, whichever occurs first, assessed up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study start12 Jan 2016
- Primary completion15 Dec 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Woyach
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacyclics LLC.
- Responsible party
- Sponsor-investigator, Jennifer Woyach, Ohio State University Comprehensive Cancer Center
- Investigators
- Jennifer Woyach, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518555
- Sponsor's protocol ID
- OSU-15012
- Other IDs
- NCI-2015-00932
- Status last verified
- Mar 2026
- First submitted
- 9 Jul 2015
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arrato NA, Valentine TR, Byrd JC, Jones JA, Maddocks KJ, Woyach JA, Andersen BL. Illness representations and psychological outcomes in chronic lymphocytic leukaemia. Br J Health Psychol. 2022 May;27(2):553-570. doi: 10.1111/bjhp.12562. Epub 2021 Oct 4.
PubMed 34608724
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention Trial of Ibrutinib for Patients With Asymptomatic, High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT02518555
- Acronym / sponsor ID
- OSU-15012
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Jennifer WoyachUniversity, hospital or other
- Collaborators
- Pharmacyclics LLC.
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well ibrutinib works when given together with vaccine therapies in treating patients without clinical signs or indications that raise the possibility of a particular disorder or dysfunction (asymptomatic) who have high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Vaccines, such as pneumococcal 13-valent conjugate vaccine, trivalent influenza vaccine, and diphtheria toxoid/tetanus toxoid/acellular pertussis vaccine adsorbed, may help the body build an effective immune response to kill cancer cells. Giving ibrutinib together with vaccine therapies may be a better treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Detailed description
PRIMARY OBJECTIVES:
- To determine the 2-year progression-free survival of asymptomatic, high-risk genomic chronic lymphocytic leukemia (CLL) patients treated with ibrutinib.
SECONDARY OBJECTIVES:
- To determine whether concurrent administration of ibrutinib with 2 doses of the pneumococcal vaccine (pneumococcal 13-valent conjugate vaccine) does not negatively impact the immune response compared to those who receive the pneumococcal vaccination with sequential therapy.
II. To determine the safety and toxicity associated with administering ibrutinib to asymptomatic, high-risk genomic CLL patients.
III. To determine the response pattern (complete response [CR] minimal residual disease [MRD]-, CR, partial response [PR], PR with lymphocytosis, stable disease [SD]) in asymptomatic, genomic high-risk patients treated with ibrutinib.
VI. To determine changes in the stress, anxiety and depressive symptoms, and related quality of life indicators from patients treated with ibrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (concurrent vaccines and ibrutinib) | Experimental | Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Drug: Ibrutinib, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Biological: Pneumococcal 13-valent Conjugate Vaccine, Other: Quality-of-Life Assessment, Biological: Trivalent Influenza VaccinePatients receive ibrutinib PO QD on days 1-28. Patients also receive pneumococcal 13-valent conjugate vaccine IM on day 1 of courses 3 and 5 and trivalent influenza vaccine IM and DTaP vaccine IM on day 1 of course 4. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. |
| Arm B (sequential vaccines and ibrutinib) | Experimental | Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Drug: Ibrutinib, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Biological: Pneumococcal 13-valent Conjugate Vaccine, Other: Quality-of-Life Assessment, Biological: Trivalent Influenza VaccinePatients receive pneumococcal 13-valent conjugate vaccine IM on day 1 of courses 1 and 3 and trivalent influenza IM and DTaP vaccine IM on day 1 of course 2. Beginning in course 4, patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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%)
Key exclusion criteria (27 listed)
- Patients meeting any of the following consensus criteria for initiating treatment for their CLL:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine AdsorbedAlso: Adacel, Daptacel, Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine, DTaPGiven IM | Biological | Arm A (concurrent vaccines and ibrutinib), Arm B (sequential vaccines and ibrutinib) |
| IbrutinibAlso: PCI-32765Given PO | Drug | Arm A (concurrent vaccines and ibrutinib), Arm B (sequential vaccines and ibrutinib) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (concurrent vaccines and ibrutinib), Arm B (sequential vaccines and ibrutinib) |
| Pharmacological StudyCorrelative studies | Other | Arm A (concurrent vaccines and ibrutinib), Arm B (sequential vaccines and ibrutinib) |
| Pneumococcal 13-valent Conjugate VaccineAlso: PCV13 Vaccine, Prevnar 13Given IM | Biological | Arm A (concurrent vaccines and ibrutinib), Arm B (sequential vaccines and ibrutinib) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (concurrent vaccines and ibrutinib), Arm B (sequential vaccines and ibrutinib) |
| Trivalent Influenza VaccineAlso: Flu prevention, Flu prophylaxis, Flu shot, Flu vaccinationGiven IM | Biological | Arm A (concurrent vaccines and ibrutinib), Arm B (sequential vaccines and ibrutinib) |
Primary outcome
Proportion of patients who are alive and progression-free
Time frame: At 2 years from the date of the first ibrutinib administration
5 secondary outcomes
Degree of response (CR MRD-,CR, PR, PR with lymphocytosis, and SD)
Time frame: Up to 4 years
Incidence of adverse events, evaluated using the NCI CTCAE version 4.0
Time frame: Up to 30 days after study treatment
Proportion of patients who achieve complete response
Time frame: Within 2 years of starting ibrutinib treatment
Time to next treatment
Time frame: Date of first ibrutinib therapy until the date of next treatment, assessed up to 4 years
Time to treatment failure
Time frame: Date of first ibrutinib therapy until the date of next treatment, date of death, or date off-study if due to toxicity, whichever occurs first, assessed up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 34608724Arrato NA, Valentine TR, Byrd JC, Jones JA, Maddocks KJ, Woyach JA, Andersen BL. Illness representations and psychological outcomes in chronic lymphocytic leukaemia. Br J Health Psychol. 2022 May;27(2):553-570. doi: 10.1111/bjhp.12562. Epub 2021 Oct 4.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Woyach, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Ibrutinib and Laboratory Biomarker Analysis in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Jennifer Woyach at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are alive and progression-free (time frame: At 2 years from the date of the first ibrutinib administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.