Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma

Completed · Phase 2

Conditions studied: Contiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Stage I Mantle Cell Lymphoma, Stage III Mantle Cell Lymphoma, Stage IV Mantle Cell Lymphoma

In brief

This study is being done to see whether or not a drug called ibrutinib can be given to patients with mantle cell lymphoma (MCL) as maintenance therapy after induction chemotherapy. This drug blocks an enzyme that affects how the lymphocytes grow and survive. The investigators hope to learn how safe and effective ibrutinib is for treating patients with MCL after responding to induction chemotherapy.

Key facts

Study ID: NCT02242097
Run by: Northwestern University
People needed: 37
Starts: 2015-01-12
Expected to finish: 2023-01-05
Last updated by the study team: 2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Northwestern University — Chicago, Illinois, United States
Northwestern University- Lake Forest Hospital — Lake Forest, Illinois, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Cleveland Clinic — Cleveland, Ohio, United States
University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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