Stage I Chronic Lymphocytic LeukemiaPhase 2MERITNCT02649387
Ibrutinib in Treating Minimal Residual Disease in Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy
A Phase 2 study testing Ibrutinib and Laboratory Biomarker Analysis in people with Stage I Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia
- What is being tested?
- Ibrutinib and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2016to 15 Jan 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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 =< 365 days prior to registration; NOTE: Patients on supportive care therapy due to use of specific induction regimen such as antibiotics may continue on those treatments at the discretion of the treating physician
- Patient must have completed a frontline induction therapy (minimum of 2 treatment cycles); NOTE: Standard therapies/therapeutic agents are defined as those listed in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of CLL; also, patients who received induction regimen as part of a clinical trial and is not necessarily mentioned in the NCCN guidelines, will also be eligible as long as the patient has completed at least 2 treatment cycles of induction regimen, achieved a clinical response (PR or CR) and is able to meet all other criteria for the study; however, patients who have previously received ibrutinib or have been randomized to ibrutinib containing arms in a clinical trial will not be eligible for this study
- Patients must have a sustained clinical response (PR, nodular PR [nPR], complete clinical response [CCR], CR with incomplete marrow recovery [CRi], CR) with documented residual disease (>= 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
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- 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 =< 1.5 x upper limit of normal (ULN)
- Total bilirubin =< 1.5 mg/dL or direct bilirubin =< 1.0 mg/dL for patients with Gilbert's syndrome
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3.5 x ULN
- Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- Since this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown, any of the following will deem the subject ineligible for the study:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
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- Use of any other experimental drug or therapy =< 28 days prior to registration on this study; NOTE: Patients on low dose prednisone (=< 10 mg) for treatment of conditions other than CLL are eligible
- Patients who have received more than 1 prior therapy; NOTE: Prior therapy is defined as any single agent or combination regimen that is included as treatment for symptomatic CLL; treatment(s) given prior to the symptomatic phase of the disease (preventive strategy) will not be considered as prior induction therapy; for the purpose of a particular therapy/regimen to be counted towards the number of prior treatments a patient must have received at least 2 cycles of the induction regimen e.g., a patient who change their treatment regimen after only 1 cycle (due to toxicity or any other reason) will not be considered to have "2" prior therapies
- Patients who have progressive disease or relapse (as defined by the IWCLL criteria) at or any time before registration on this study
- Patients with history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off therapy for that disease for > 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: Minimal Residual Disease Eradication With Ibrutinib Therapy (MERIT) in Patients With Chronic Lymphocytic Leukemia After Frontline Therapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the rate of minimal residual disease (MRD)-negative responses (in both blood and bone marrow) at any time during treatment with ibrutinib maintenance.
SECONDARY OBJECTIVES:
- Median time to achieve MRD- (negative) status (in blood and in bone marrow) after initiation of ibrutinib maintenance treatment.
II. Toxicity profile of ibrutinib as maintenance therapy after frontline induction.
III. Durability of the MRD- state (determined from the time of first documentation of MRD- until the first documentation of MRD+ (positive) (or last date shown to be MRD- for a censor).
IV. Determine the number of patients who improve their remission category (i.e., upgrade clinical response achieved after the induction such as from partial response [PR] to complete response [CR]) after initiating the maintenance therapy.
- Time to requirement of next therapy for patients who achieve confirmed MRD- vs. those who remain MRD+ disease at 48 weeks (end of 12 cycles).
VI. Progression free survival (as determined by the International Workshop on Chronic Lymphocytic Leukemia [IWCLL] criteria) among patients who achieve confirmed MRD- vs. those who remain MRD+ disease at 48 weeks (end of 12 cycles).
TERTIARY OBJECTIVES:
- To conduct correlative studies for further understanding of the mechanism of antitumor activity of ibrutinib in eradication of the MRD.
II. Determine the impact of ibrutinib on depression and anxiety symptoms to better understand toxicity profile of ibrutinib maintenance.
III. Determine impact of social support or lack thereof on mood symptoms in chronic lymphocytic leukemia (CLL) patients receiving maintenance treatment.
OUTLINE:
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 4 weeks* for up to 36 courses in the absence of disease progression or unacceptable toxicity.
Note: *The last course may last up to 56 days to accommodate the study drug discontinuation visit.
After completion of study treatment, patients are followed up every 3-6 months for up to 2 years.
- Conditions
- Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia
- Being tested
- Ibrutinib, Laboratory Biomarker Analysis
- 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.
IbrutinibDrug
Also called BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ibrutinib) | Experimental | Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks* for up to 36 courses in the absence of disease progression or unacceptable toxicity.
Note: *The last course may last up to 56 days to accommodate the study drug discontinuation visit. Receives: Drug: Ibrutinib; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Confirmed MRD-negative Response
This outcome is summarized by the proportion of patients achieving MRD negative status. A confirmed MRD-negative response is defined as an achievement of MRD-negative status in both the blood and the bone marrow on two consecutive evaluations at least 3 months apart.
Measured: 3 years
Secondary outcomes (5)
Duration of MRD-negative Response
Defined as the time from the earliest date that the patient was noted as having MRD-negative response in both the blood and bone marrow until the first notation of MRD positive disease in the blood or the bone marrow.
Measured: Not started
Incidence of Adverse Events
Will be graded according to the Grading Scale for Hematologic Adverse Events in CLL Studies. The count of patients that experienced a grade 3 or higher adverse event, regardless of attribution, will be reported.
Measured: Up to 30 days after the last day of study drug treatment
Progression-free Survival
Defined as the time from the 48-week MRD evaluation until the time of disease progression per the IWCLL criteria or death due to any cause
Measured: Not started
Time to MRD-negative Response
Defined as the time from the date of registration to the earliest date that the patient was noted as having MRD-negative response in both the blood and bone marrow
Measured: Not started
Time to Requirement of Next Therapy
Defined as the time from the 48-week MRD evaluation until the time of initiation of subsequent treatment for progressive CLL
Measured: Not started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start8 Feb 2016
- Primary completion14 Dec 2023
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage I Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asher Chanan-Khan, M.D., Principal investigator, Mayo ClinicSikander Ailawadhi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649387
- Sponsor's protocol ID
- MC1481
- Other IDs
- NCI-2015-02153, 15-004991
- Acronym
- MERIT
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2016
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Residual Disease Eradication With Ibrutinib Therapy (MERIT) in Patients With Chronic Lymphocytic Leukemia After Frontline Therapy
- ClinicalTrials.gov ID
- NCT02649387
- Acronym / sponsor ID
- MERIT / MC1481
- Conditions
- Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Feb 2016 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Posted 24 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Determine the rate of minimal residual disease (MRD)-negative responses (in both blood and bone marrow) at any time during treatment with ibrutinib maintenance.
SECONDARY OBJECTIVES:
- Median time to achieve MRD- (negative) status (in blood and in bone marrow) after initiation of ibrutinib maintenance treatment.
II. Toxicity profile of ibrutinib as maintenance therapy after frontline induction.
III. Durability of the MRD- state (determined from the time of first documentation of MRD- until the first documentation of MRD+ (positive) (or last date shown to be MRD- for a censor).
IV. Determine the number of patients who improve their remission category (i.e., upgrade clinical response achieved after the induction such as from partial response [PR] to complete response [CR]) after initiating the maintenance therapy.
- Time to requirement of next therapy for patients who achieve confirmed MRD- vs. those who remain MRD+ disease at 48 weeks (end of 12 cycles).
VI. Progression free survival (as determined by the International Workshop on Chronic Lymphocytic Leukemia [IWCLL] criteria) among patients who achieve confirmed MRD- vs. those who remain MRD+ disease at 48 weeks (end of 12 cycles).
TERTIARY OBJECTIVES:
- To conduct correlative studies for further understanding of the mechanism of antitumor activity of ibrutinib in eradication of the MRD.
II. Determine the impact of ibrutinib on depression and anxiety symptoms to better understand toxicity profile of ibrutinib maintenance.
III. Determine impact of social support or lack thereof on mood symptoms in chronic lymphocytic leukemia (CLL) patients receiving maintenance treatment.
OUTLINE:
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 4 weeks* for up to 36 courses in the absence of disease progression or unacceptable toxicity.
Note: *The last course may last up to 56 days to accommodate the study drug discontinuation visit.
After completion of study treatment, patients are followed up every 3-6 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ibrutinib) | Experimental | Drug: Ibrutinib, Other: Laboratory Biomarker AnalysisPatients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks* for up to 36 courses in the absence of disease progression or unacceptable toxicity. Note: *The last course may last up to 56 days to accommodate the study drug discontinuation visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 =< 365 days prior to registration; NOTE: Patients on supportive care therapy due to use of specific induction regimen such as antibiotics may continue on those treatments at the discretion of the treating physician
- Patient must have completed a frontline induction therapy (minimum of 2 treatment cycles); NOTE: Standard therapies/therapeutic agents are defined as those listed in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of CLL; also, patients who received induction regimen as part of a clinical trial and is not necessarily mentioned in the NCCN guidelines, will also be eligible as long as the patient has completed at least 2 treatment cycles of induction regimen, achieved a clinical response (PR or CR) and is able to meet all other criteria for the study; however, patients who have previously received ibrutinib or have been randomized to ibrutinib containing arms in a clinical trial will not be eligible for this study
Key exclusion criteria (17 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- Since this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown, any of the following will deem the subject ineligible for the study:
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Use of any other experimental drug or therapy =< 28 days prior to registration on this study; NOTE: Patients on low dose prednisone (=< 10 mg) for treatment of conditions other than CLL are eligible
- Patients who have received more than 1 prior therapy; NOTE: Prior therapy is defined as any single agent or combination regimen that is included as treatment for symptomatic CLL; treatment(s) given prior to the symptomatic phase of the disease (preventive strategy) will not be considered as prior induction therapy; for the purpose of a particular therapy/regimen to be counted towards the number of prior treatments a patient must have received at least 2 cycles of the induction regimen e.g., a patient who change their treatment regimen after only 1 cycle (due to toxicity or any other reason) will not be considered to have "2" prior therapies
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 |
|---|---|---|
| IbrutinibAlso: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765Given PO | Drug | Treatment (ibrutinib) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (ibrutinib) |
Primary outcome
Rate of Confirmed MRD-negative Response
Time frame: 3 years
This outcome is summarized by the proportion of patients achieving MRD negative status. A confirmed MRD-negative response is defined as an achievement of MRD-negative status in both the blood and the bone marrow on two consecutive evaluations at least 3 months apart.
5 secondary outcomes
Duration of MRD-negative Response
Time frame: Not started
Incidence of Adverse Events
Time frame: Up to 30 days after the last day of study drug treatment
Progression-free Survival
Time frame: Not started
Time to MRD-negative Response
Time frame: Not started
Time to Requirement of Next Therapy
Time frame: Not started
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Asher Chanan-Khan, M.D. principal investigator
Mayo Clinic
Sikander Ailawadhi, M.D. principal investigator
Mayo Clinic
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 Ibrutinib and Laboratory Biomarker Analysis in people with Stage I Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia, run by Mayo Clinic 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 13 inclusion and 17 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 25 Sep 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?
Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Confirmed MRD-negative Response (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.