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.
PRIMARY OBJECTIVES: I. To determine the progression-free survival (PFS) rate after 3 years. SECONDARY OBJECTIVES: I. Assess toxicity. II. Determine rates of conversion from partial response (PR) to complete response (CR). III. Determine median overall survival (OS) after 4 years. TERTIARY OBJECTIVES: I. Compare minimal residual disease (MRD) results overtime by polymerase chain reaction (PCR) and correlate these with PFS and OS. OUTLINE: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity or patient preference. After completion of study treatment, patients who completed 4 years of treatment are followed up at 30 days. Patients who did not complete 4 years of treatment are followed up for up to 4 years post-first dose of treatment (every 3 months for 2 years and then every 6 months for 4 years).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Given PO
Correlative studies
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
Determine the Progression-free Survival (PFS) Rate After 3 Years
PFS will be measured from start of treatment to time of progression. Evidence of clinical progression will be documented by imaging (CT scan) for patients who have measurable disease. Progression is defined using the LUGANO Criteria, as a Deauville score of 4 or 5 (increased uptake compared to baseline) or the appearance of new lesions
Time frame: Assessed at 3 years
Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0
To assess toxicity, all adverse events will be summarized as to type, severity, frequency, timing and attribution. Treatment related Adverse Events Occurring with Incidence of greater that or equal to 20% of patients treated with Ibrutinib Maintenance are shown here.
Time frame: Up to 30 days after completion of study treatment, maximum 4 years post-first dose
Rate of Conversion From Partial Response (PR) to Complete Response (CR)
Progression will be evaluated using Cheson 2007 criteria, only patients who had a PR at the time of registration and who complete ≥ 1 complete cycle of ibrutinib maintenance therapy will be evaluable for this endpoint.
Time frame: Up to 4 years
Overall Survival (OS) After 4 Years
Patients will be evaluated monthly for the first 6 months on treatment, then every 3 months thereafter. Patients who go off treatment will continue to be followed for up to 4 years post-first dose. Follow-up will occur every 3 months (up to 2 years after the first dose of treatment) and then every 6 months thereafter (up to 4 years post-first dose). OS after 4 years will be calculated as a percentage of patient alive.
Time frame: Up to 4 years post-first dose
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