Can a pill keep mantle cell lymphoma away? new study tests ibrutinib maintenance
NCT ID NCT02242097
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether the drug ibrutinib can safely keep mantle cell lymphoma from returning after initial chemotherapy. Thirty-seven patients who had already responded to chemo took ibrutinib as a maintenance therapy. Researchers tracked how long patients stayed cancer-free and what side effects occurred.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ibrutinib
- What this could lead to
- If it works, this could offer a way to keep mantle cell lymphoma from coming back longer after initial treatment.
- What could go wrong
- This is a small, early-phase study (37 people) with no comparison group, so results may not be definitive. Ibrutinib can cause side effects like bleeding, infection, or heart issues.
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
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37 people
The number who actually took part.
- Started
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Jan 2015
- Finished
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Jan 2023
- 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 confirmed mantle cell lymphoma (MCL) * Please note: Measurable disease is not required, but will be followed if it exists * Patients must have received 4 or more cycles of one of the following prior systemic induction chemotherapy regimens: * Rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunomycin), vincristine sulfate (Oncovin), prednisone (R-CHOP) (with or without alternating rituximab, dexamethasone, cytarabine \[ara-c\], cisplatin \[platinum\] \[R-DHAP\]) with or without autologous (auto) stem cell transplant (SCT) * Hyper-cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride (adriamycin), dexamethasone (CVAD) with or without auto SCT * Bendamustine + rituximab with or without auto SCT * Please note: * Patients who received combinations of the above regimens are not eligible for enrollment * At the time of registration, patients must be at least 14 days out from last dose of cytotoxic chemotherapy, but no more than 90 days; if a patient underwent auto SCT, he/she must demonstrate engraftment (per treating investigator's discretion) and must meet all other hematological requirements as outlined below * Patients must have achieved a response to induction chemotherapy (either CR or PR by Cheson 2007 criteria) and be without known progression * Patients may have received prior radiotherapy * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Absolute neutrophil count (ANC) \>= 1000/mm\^3, independent of growth factor support * Platelets \>= 100,000/mm\^3, or \>= 50,000 in cases of ongoing bone marrow involvement (in either case, these must be independent of transfusion support) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SPGT\]) =\< 3 x ULN * Creatinine clearance \>= 25 ml/min * Please note: Patients who do not meet the above criteria because of Gilbert's Syndrome are still eligible * Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation (see timelines below for women and men); in addition, men must agree not to donate sperm during and after study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * NOTE: For female patients, these restrictions apply for 1 month after the last dose of study drug; for male patients, these restrictions apply for 3 months after the last dose of study drug * NOTE: A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Female patients must have a negative pregnancy test (blood or urine) within 28 days prior to registration * Patients must be willing and able to avoid consuming food and beverages containing grapefruit or Seville oranges while on ibrutinib study therapy * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria: * Patients who have received \>= 7 days of prior ibrutinib or any prior treatment with another Bruton tyrosine kinase (BTK) inhibitor are not eligible * Patients receiving ongoing treatment with any other investigational agents are not eligible * Patients receiving live/attenuated vaccinations within 4 weeks prior to registration are not eligible * Patients with a known central nervous system (CNS) involvement of lymphoma are not eligible (CNS staging not required) * Patients who have undergone major surgery within 4 weeks prior to registration are not eligible * Patients diagnosed or treated for malignancy other than MCL are not eligible unless they meet one of the following exceptions: * Malignancy treated with curative intent and with no known active disease present for \>= 3 years before registration and felt to be at low risk for recurrence by the treating physician * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * Adequately treated cervical carcinoma in situ without evidence of disease * Patients with a history of stroke or intracranial hemorrhage within 6 months prior to registration are not eligible * Patients who require anticoagulation with warfarin or equivalent vitamin K antagonists are not eligible * Patients who require chronic treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) inhibitors are not eligible * NOTE: Patients who are currently on treatment with strong CYP3A4/5 inhibitors may be eligible if they are able to be switched to an alternative therapy that is not a strong CYP3A4/5 inhibitor prior to registration on study * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib are not eligible * Patients with uncontrolled intercurrent illness including, but not limited to, any of the following are not eligible: * Ongoing or active systemic infection * Symptomatic congestive heart failure * Myocardial infarction within 6 months prior to registration * Unstable angina pectoris * Uncontrolled or symptomatic cardiac arrhythmias * Any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification * Psychiatric illness/social situations that would limit compliance with study requirements * Patients who have any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at risk are not eligible * Patients with a known human immunodeficiency virus (HIV) infection are not eligible (HIV testing not required) * Patients with a known John Cunningham (JC) virus infection and/or progressive multifocal leukoencephalopathy (PML) are not eligible * Patients with clinically active hepatitis A, B, or C infections are not eligible * Female patients who are pregnant and/or lactating are not eligible
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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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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Northwestern University- Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
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University of Utah
Salt Lake City, Utah, 84132, United States
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